US20160213843A1 - Smart portable infusion pump - Google Patents
Smart portable infusion pump Download PDFInfo
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- US20160213843A1 US20160213843A1 US15/004,828 US201615004828A US2016213843A1 US 20160213843 A1 US20160213843 A1 US 20160213843A1 US 201615004828 A US201615004828 A US 201615004828A US 2016213843 A1 US2016213843 A1 US 2016213843A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
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- A61M2205/00—General characteristics of the apparatus
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- A61M2205/276—General characteristics of the apparatus preventing use preventing unwanted use
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- A61M2205/00—General characteristics of the apparatus
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- A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/502—User interfaces, e.g. screens or keyboards
- A61M2205/505—Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/60—General characteristics of the apparatus with identification means
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/60—General characteristics of the apparatus with identification means
- A61M2205/6063—Optical identification systems
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/36—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body
- A61M5/365—Air detectors
Definitions
- This invention relates to infusion pumps, and more particularly, relates to portable infusion pumps with smart capabilities for providing fluids to patients in need of therapeutic treatments.
- Infusion pumps are medical devices that provide delivery of measured amounts of infusates, which are fluids such as medicine or nutrients, to a patient. Infusion pumps allow for delivery of precise volumes of fluids, including very small volumes, at precise intervals or rates. Infusion pumps currently on the market have programmable interfaces that allow for customizable therapeutic treatment regimens. Existing devices can store and retrieve drug libraries and have safeguards capable of preventing gross programming errors if ineffective or life-threatening infusion parameters are attempted for a particular drug. Existing infusion pumps may also connect to the electronic medical records system of the care facility in which they operate.
- Infusion pumps can be difficult to set up, to program, and to operate. For this reason, they generally require trained medical personnel to operate.
- Existing pumps also tend to be large and bulky, restricting the ability for a patient to leave a treatment area while continuing to receive care or from moving within a treatment area.
- One aspect of the invention is a smart programmable infusion device that contains a driving element of an infusion pump as well as a plurality of smart modules to detect a condition of use of the infusion pump and communicate that information to a patient.
- One embodiment is a device for confirming the identity of a patient, the identity of an infusate, or the dosage amount of an infusate. This aspect can be achieved by providing one or more identification sensors.
- Another embodiment of the present invention is a device for preventing infusion if an infusate is not in suitable condition for infusion or if the infusion is not being administered properly.
- This aspect can be achieved by providing one or more sensors related to conditions affecting the infusate or of the infusion process.
- Another embodiment is a method of operating a programmable infusion device comprising a plurality of smart modules.
- Another embodiment of the present invention is a method of detecting the identity of a patient, the identity of an infusate, or the dosage amount of an infusate.
- data related to the identity of a patient, the identity of an infusate, or the dosage amount of an infusate can be transmitted to an external device.
- Another embodiment is a method of detecting the condition of use of an infusate and an infusion device.
- data related to the condition of use of an infusate or of an infusion device can be transmitted to an external device.
- FIG. 1A depicts a front perspective view of an infusion device in accordance with an illustrative embodiment of the present invention.
- FIG. 1B depicts a rear perspective view of an infusion device in accordance with an illustrative embodiment of the present invention.
- FIG. 2 depicts a cut-away perspective view showing the interior of an infusion device in accordance with an illustrative embodiment of the present invention.
- FIG. 3 depicts a schematic view of an infusion device in accordance with an illustrative embodiment of the present invention.
- FIG. 4 depicts a flowchart of an embodiment of a method of operating an infusion device in accordance with an illustrative embodiment of the present invention.
- FIG. 5 depicts a flowchart of an embodiment of confirming identification parameters in an infusion device in accordance with an illustrative embodiment of the present invention.
- FIG. 6 depicts a flowchart of an embodiment of monitoring sensor parameters in an infusion device in accordance with an illustrative embodiment of the present invention.
- FIG. 7A depicts an infusion device in accordance with an illustrative embodiment of the present invention.
- FIG. 7B depicts an infusion device in accordance with an illustrative embodiment of the present invention.
- One embodiment of the invention is an intelligent portable infusion device that includes an integrated infusion pump in a lightweight and handheld form factor.
- the infusion pump may be made up of a driving element and an infusion pump head, as described in more detail below.
- the infusion pump is a volumetric infusion pump. Such pumps may be used, among other applications, to treat patients undergoing chemotherapy.
- the infusion device is made of two principle components, one being a smart device such as a cellular telephone, and the other being an infusion device that is configured to pump fluids.
- the cellular telephone may mate with the infusion device and run applications allowing the cellular telephone to control the operation of the infusion device.
- the infusion device is a cradle that is adapted to electrically and mechanically mate with a cellular telephone. A user may then control the infusion device by inputting commands to a touch screen of the cellular telephone to thereby control the operation of the infusion device.
- the infusion device may include a supplemental battery to extend the useful operating time of the cellular telephone while connected to the infusion device.
- the infusion device may have a portable durable housing that contains a touch screen or other user interface control system for inputting and monitoring the operation of the device.
- Including all of the elements of an intelligent infusion pump in a small portable device allows medicament infusion to be readily administered at a medical facility, in the home, or in an ambulatory setting.
- the infusion device can also allow freedom of movement for a patient undergoing an infusion.
- the infusion device may be reusable, allowing for a clinician or emergency medical technician to treat multiple patients using the same pump.
- the portable durable housing contains the driving element of an intelligent infusion pump, as well as a plurality of smart modules and sensors.
- the portable durable housing can be configured to engage a pump head, the pump head being configured to further engage a disposable fluid path.
- the driving element in the portable durable housing can be configured to cause motion in the pump head, displacing fluid within the disposable fluid path.
- the pump head may be disposable, allowing for multiple pump heads to be used with the same infusion device.
- the disposable feature of the pump head can decrease the risk of contamination when administering multiple fluids to multiple patients.
- the pump head may further be packaged as part of the disposable fluid head to allow for easy assembly and use of the infusion device.
- the driving element of the infusion device may be configured to engage and drive multiple types of pump heads.
- the infusion device is configured to be programmable by a user.
- Infusion pumps provide the delivery of a measured amount of infusates.
- the infusion device can comprise a user interface displayed on a touch screen for programming one or more infusion parameters. These parameters can include the fluid to be administered, amount of dose, rate of dose administration, and intervals at which the dose is to be administered.
- the infusion device further comprises a computing module containing one or more microprocessors that receive programmed instructions from the user interface or from an external device and can transmit those instructions to the infusion driving element so that an infusion is administered according to the programmed instructions.
- the infusion device can include one or more environmental sensors capable of monitoring and detecting external events or characteristics associated with the use of the infusion device.
- Exemplary environmental sensors can be configured to measure temperature, flow, pressure, and the presence of air in fluid.
- the sensors may detect a state of a fluid being administered to a user.
- the smart device can also include a computing module configured to process data from the sensors to determine a state of the fluid being administered. Thus, the smart device can verify cold chain and drug authenticity. Once the state of the fluid is determined, the computing module may determine if the fluid is ready for infusion to a patient. If the fluid is not ready for infusion, the device can be configured with safeguards to prevent the administration of infusion if the fluid is not ready for use, or if the device is programmed to deliver a dangerous or ineffective amount of fluid.
- the infusion device may further include one or more identification sensors including, but not limited to, a digital camera, a radio frequency (RF) tag reader and a bar code scanner.
- the identification sensors can be configured to ascertain the identity of the infusate being administered by the infusion device. If the correct infusate is not identified by the identification sensor, the infusion device may be configured to prevent administration of the infusate.
- An identifier, such as a bar code or RF tag can also contain dosage information. Thus, the identification sensors may also be configured to identify the dosage of the medicine about to be delivered to the user. If the correct dose is not identified by the identification sensor, the infusion device may be configured to prevent administration of the fluid.
- the infusion device can be configured to prevent infusion, terminate infusion, or prevent further infusion based on the occurrence of one or more predetermined events, such as, for example, determination that data from one or more environmental sensors is outside of a defined range, determination from one or more identification sensors that a correct patient, a correct infusate, or a correct dosage has not been identified, and determination that a full dosage has been administered to a patient.
- one or more predetermined events such as, for example, determination that data from one or more environmental sensors is outside of a defined range, determination from one or more identification sensors that a correct patient, a correct infusate, or a correct dosage has not been identified, and determination that a full dosage has been administered to a patient.
- an identifier such as a bar code or RF tag can include information about the origin of an infusate, the transportation of an infusate, and any transactions involving the infusate.
- the identification sensors may further be configured to confirm drug pedigree.
- medical personnel may use the same device for more than one user.
- An identifier, such as a bar code or RF tag may be attached to a patient.
- the identification sensor can be configured to identify a particular patient. If the intended patient is not identified, the smart device may be configured to prevent administration of the fluid.
- the device may include a camera and perform facial recognition to identify the authorized user.
- An application running on the infusion device can direct a user to take a facial picture using the camera.
- the application can further provide visual indicators on a touch display to assist the user in aligning their face with the camera.
- the user may then take a facial picture, which can be transmitted to the computing module of the infusion device.
- the facial picture can be compared to a database of patient pictures stored in a memory of the infusion device.
- the facial picture may be transmitted to an external device or server containing a database of patient pictures for comparison.
- the infusion device may further include a communication module to allow for connectivity between the infusion device and external devices. This allows information from the infusion device to be transmitted to interested parties including the patient, payers, pharmacies and clinicians.
- the communication module may be configured to perform short-distance RF communication, such as Bluetooth, BLE, or ZigBee®.
- the communication module may also be configured to perform long distance wireless communication through cellular protocols such as 3G, 4G/LTE, or WiMax.
- the communication module may also be configured to automatically connect with the electronic medical records system of a user's care facility.
- the communication module may also allow a user to engage in real-time communication with a clinician.
- the infusion device may allow for instant messaging, telephonic communications, or real-time video communication.
- the infusion device can further be configured to store contact information including phone numbers, e-mail addresses, and instant messaging addresses of clinicians, pharmacies, and emergency services in the memory of the infusion device.
- the infusion device may further include a location sensor, which can be used to allow a user to contact the nearest emergency services provider.
- the infusion device may further include a camera.
- the camera can allow a user to take a picture or video of his or her face so that a clinician can positively identify the user.
- the camera may also allow a user to engage in a video conversation with a physician. The physician may then provide treatment or device usage advice to the user and answer any questions the user presents in the course of treatment.
- the camera may also perform facial recognition to identify and authenticate a user before the system allows the pump to be activated.
- a fingerprint sensor or other input component on the infusion device may be used for authentication.
- An application running on the infusion device may direct the user to align their finger with one or more visual indicators on the touch display.
- the infusion device may capture the fingerprint and transmit the fingerprint data to the computing module of the infusion device or to an external device or server. The fingerprint can then be compared to a database of fingerprints to determine if there is a match.
- various forms of password protection may be utilized to prevent access to the infusion device, including textual and motion based passwords.
- the infusion device may further be configured to provide various notifications to a user.
- the notifications can relate to confirmation of identity, the state of an infusate, the state of an infusion, and the receipt of communication.
- the notifications can comprise visual notification on the touch display, auditory notification such as a chirp or beep, or tactile notification such as vibration of the infusion device.
- auditory notification such as a chirp or beep
- tactile notification such as vibration of the infusion device.
- FIGS. 1A and 1B depict a front and rear view of an illustrative embodiment of an infusion device 100 .
- the infusion device 100 includes a rectangular housing 102 that is shaped to hold components of the infusion device 100 .
- a touch display 104 Positioned on a front face of the housing 102 is a touch display 104 that allows a user to enter commands to the infusion device 100 .
- the touch display 104 can use any well-known technology for registering single or multiple touch events and performing predetermined actions based on each touch.
- the housing also includes a digital camera 175 mounted centrally above the touch display 104 and configured to capture digital images.
- the pump head 110 mounts to the infusion device 100 through a pump head connection port 114 .
- the pump head 110 also includes a pair of fluid path connectors 112 A,B which are configured to mate with tubing that contains the liquid to be pumped.
- an air bubble detector 115 Also provided along the lower portion of the housing 102 , and adjacent the pump head connection port 114 is an air bubble detector 115 .
- the touch display 104 , the camera 175 , the pump head connection port, and the air bubble detector 115 are located within the housing 102 .
- the housing 102 may comprise a durable material such as plastic or metal.
- the housing 102 may be designed to be ergonomically comfortable for the user. In other embodiments, the housing 102 may also include handgrips.
- a disposable fluid path is aligned to engage with the fluid path connecters 112 A,B and the air bubble detector 115 .
- the disposable fluid path may comprise two or more sections of flexible tubing.
- a section of flexible tubing can extend from the source of the fluid and engage fluid path connector 112 A.
- Another section of flexible tubing can engage fluid path connecter 112 B and can be inserted into air bubble detector 115 .
- the other end of the flexible tubing engaged with fluid path connecter 112 B can lead to a patient undergoing an infusion treatment.
- the pump head 110 can comprise a positive displacement pump head, such as a rotary pump head or reciprocating motion based displacement pump head.
- a positive displacement pump head such as a rotary pump head or reciprocating motion based displacement pump head.
- the pump head 110 is not limited to a rotary pump head, but may comprise any pump head known in the art.
- the pump head 110 would be activated, which would then cause fluid to move along the tubing.
- the fluid moves from the source of fluid to fluid path connecter 112 A.
- the fluid then enters the pump head 110 .
- fluid is driven by the pump head 110 out of fluid path connecter 112 B.
- the fluid then traverses the flexible tubing connected to fluid path connecter 112 B through the air bubble detector 115 and towards the patient.
- the pump head 110 may be removable from the housing 102 .
- the pump head 110 can thereby be configured to work with multiple infusion devices.
- the pump head 100 can be disposable.
- a driving element can be configured to engage multiple types of pump heads.
- the housing 102 and all elements incorporated within the housing 102 , can be repeatedly used with multiple patients and multiple infusates.
- the pump head 110 may come integrated within a disposable fluid path, the entirety of which may then engage with the infusion device in order to administer an infusion.
- the air bubble detector 115 may comprise, but is not limited to, an ultrasonic air bubble detector.
- the infusion device 100 may be configured to prevent the administration of fluid if an air bubble is detected in the fluid path by air bubble detector 115 .
- the air bubble detector 115 may also comprise one or more infusion-related sensors.
- the one or more infusion related sensors can comprise, but are not limited to, a temperature sensor, motion sensor, optical sensor, Hall effect sensor, flow sensor, and a pressure sensor.
- the camera 175 can be configured to obtain pictures or video.
- a picture may be taken of a patient to confirm identity.
- Video may be used to allow a patient to send a video communication to another party such as a clinician, payer, or pharmacy.
- the touch display 104 is configurable to allow for programming of the infusion device 100 .
- the touch display 104 can be used to enter a dosage amount, intervals at which doses should occur, or a rate at which an infusate is administered to a patient.
- the touch display 104 can also display information to a user related to the condition of the infusate or the state of the infusion event. This information can be detected by one or more infusion-related sensors or identification sensors housed in the interior of the infusion device 100 .
- the information can include, but is not limited to, temperature, pressure, end of dose, rate of dose, presence of air in fluid path, identity of drug, dosage amount of drug, identity of patient, time of infusion, and location of infusion.
- the touch display 104 may also be configured to allow a user to transmit information from the sensors to other parties including, but not limited to, clinicians, payers, or pharmacies.
- the touch display 104 may also be configured to allow a user to communicate with an external device.
- the touch display 104 can be configured to allow a user to input textual information to transmit that information to an external device.
- the touch display 104 can further be configured to allow a user to perform database querying by inputting textual information.
- the touch display 104 may also allow a user to open and view textual communications received from another party.
- the touch display 104 may also be configured to allow a user to initiate, control, and terminate an audio conversation, video conversation, or real-time textual conversation with another party. In the case of a video conversation, the touch display 104 may display the video received from another party.
- the touch display 104 may be configured to allow a user to operate the camera 175 , to view images obtained using camera 175 , and to transmit those images to an external device.
- touch display 104 is not limited to a touch display, but may comprise any input and display mechanism known in the art.
- touch display 104 may comprise a keyboard and a display screen.
- the touch display 104 may comprise a display screen and the operation performed on the screen may be voice controlled.
- the touch display 104 may include multiple methods of input, including, but not limited to, touch screen, keyboard, and voice control.
- the infusion device 100 may further include an orientation sensor. The infusion device can be configured to perform specified functions in response to the orientation or movement of the infusion device.
- FIG. 2 depicts the interior of an infusion device 100 in accordance with an illustrative embodiment of the present invention.
- the infusion device 100 includes the housing 102 , an infusion driving element 120 , the pump head 110 , the air bubble detector 115 , and an electronics package 127 .
- the driving element 120 includes a motor 122 .
- the motor can comprise any electric motor known in the art, including, but not limited to, a brushed direct current (DC) electric motor, a brushless motor, a stepper motor, a servomotor, a gearmotor, a hollow shaft motor, or a shaftless motor.
- the driving element 120 further includes a shaft 124 and a pump head connection 126
- the driving element 120 causes rotary or reciprocal motion within the pump head 110 .
- the rotary or reciprocal motion within the pump head 110 causes the displacement of fluid along a disposable fluid path.
- the electronics package 127 may comprise one or more infusion-related sensors, one or more identification sensors, a power module, a communication module, a computing module, a location module, and a memory.
- FIG. 3 depicts a schematic view of the infusion device 100 .
- the infusion device 100 comprises the housing 102 , the infusion driving element 120 , the pump head 110 , the camera 175 , a microphone 180 , the touch display 104 , the air bubble detector and the electronics package 127 .
- the infusion driving element 120 further comprises the motor 122 , the shaft 124 , and the pump head connection 126 .
- the electronics package 127 further comprises a power module 155 , a computing module 160 , a communication module 165 , a motion actuation module 168 , a motion control module 170 , one or more identification sensors 185 , one or more infusion sensors 190 , a location module 195 , and a memory 198 .
- the computing module 160 may contain one or more microprocessors.
- the housing 102 houses the infusion driving element 120 , the camera 175 , the microphone 180 , the touch display 104 , the air bubble detector 115 , and the electronics package 127 .
- the pump head 110 engages the pump head connection 126 of the infusion driving element 120 .
- the infusion driving element 120 , the pump head 110 , the camera 175 , the microphone 180 , the touch display 104 , the air bubble detector 115 , the infusion sensors 190 , the identification sensors 185 , the location sensors 195 , the motion control module 170 , and the motion actuation module 168 are in communication with the computing module 160 .
- the computing module 160 is further in communication with the memory 198 and the communication module 165 .
- the housing 102 may comprise one or more pieces that can separately, partially or fully enclose one or more of the infusion driving element 120 , the pump head 110 , the camera 175 , the microphone 180 , the touch display 104 , the air bubble detector 115 , and the electronics package 127 .
- the housing 102 can be adapted to include openings for access to features of the infusion device including, but not limited to, the touch display 104 , the camera 175 , the microphone 180 , the air bubble detector 115 , buttons, keyboards, screens, interfaces, plugs, jacks, sockets, and speakers.
- the housing 102 may be further adapted to include room for wires, cords, or any other connection elements that may be attached to the infusion device 100 .
- the infusion device 100 allows for the programming of the infusion device using the touch display 104 .
- a user can input a plurality of infusion parameters including, but not limited to, fluid to be administered, amount of dose, rate of dose administration, and intervals at which the dose is to be administered.
- the programmed data is transmitted to the computing module 160 .
- the computing module 160 then performs on-board processing to determine if the programmed infusion parameters are within a safe and effective range. If the programmed parameters are within a safe and effective range, the device may be ready for infusion.
- the infusion device will commence infusion when it is found that the programmed parameters are within a safe and effective range.
- the computing module 160 can transmit a signal indicative of instructions to the motor 122 of the infusion driving element 120 .
- the instructions can include, but are not limited to, a start command, a stop command, a direction command, and a speed command.
- the infusion element 120 can administer infusion in accordance with the programmed parameters.
- a notification may be transmitted to the touch display 104 stating that the programmed parameters are acceptable, and then a further step must be taken to initiate infusion.
- a button on the touch display 104 can be engaged to initiate infusion.
- the infusion device 100 can also be configured to allow for programming from an external device.
- an external device can transmit programming data to the communication module 165 .
- the communication module 165 can then transmit the programming data to the computing module 160 .
- the infusion device can also be configured to allow for programming using the microphone 180 .
- the microphone 180 can transmit audio data to the computing module 160 .
- the computing module 160 may contain speech recognition software.
- the computing module 160 may then translate the audio data in to programmed parameters.
- the touch display 104 can also be configured to provide for the transmission of data to an external device. For example, a textual message can be entered using the touch display 104 . The textual message can then be transmitted to the communication module 165 . After receiving the textual message, the communication module 165 can be configured to transmit the textual message to an external device. The touch display 104 can also be configured to display data transmitted from an external device and received at the communication module 165 .
- the identification sensors 185 can include, but are not limited to an RF tag reader or a bar code scanner.
- a care facility may attach an RF tag or bar code to a patient on, for example, a wristband.
- the identification sensors 185 can detect the identity of the RF tag or bar code on a patient and transmit that data to the computing module 160 .
- the computing module 160 can be configured to compare the identification information from the identification sensors 185 to information programmed into the infusion device 100 . If the identity of the patient is not confirmed, the computing module 160 can be configured to prevent infusion from occurring. In response to confirming or not confirming the identity of a patient, the computing module 160 can also be configured to transmit a message to the touch display 104 .
- the touch display may be configured to display a state of confirmation including confirmed, not confirmed, or error.
- the infusion device 100 can further transmit a message to an external device through the communication module 165 stating that identity is confirmed or not confirmed.
- the infusion device 100 can be configured to confirm the identity of the patient prior to commencing infusion.
- one or more identification sensors 185 can be configured to confirm the identity of a patient.
- the camera 175 may also be configured to confirm the identity of a patient.
- the camera 175 can capture picture or video of a patient.
- the image data captured by the camera 175 can be transmitted to the computing module 160 .
- the computing module 160 can be configured to perform on-board processing to determine if the image data captured by the camera matches an image of the patient in a database. If the identity of the patient is not confirmed, the computing module 160 can be configured to prevent infusion from occurring.
- the image data can be transmitted to the communication module 165 .
- the image data can be transmitted to an external device.
- the image data is transmitted to a treating clinician who will confirm the identity of the patient.
- the image data can be compared to an image of a patient in a database at the external device.
- the computing module 160 can also be configured to transmit a message to the touch display 104 .
- the touch display may be configured to display a state of confirmation including confirmed, not confirmed, or error.
- the one or more identification sensors 185 can also be configured to confirm the identity of an infusate.
- An infusate may be labeled with an RF tag or bar code.
- the identification sensors 185 can detect the identity of the RF tag or bar code on the infusate and transmit that data to the computing module 160 .
- the computing module 160 can be configured to compare the identification information from the identification sensors 185 to information programmed into the infusion device 100 . If the identity of the infusate is not confirmed, the computing module 160 can be configured to prevent infusion from occurring. In response to confirming or not confirming the identity of an infusate, the computing module 160 can also be configured to transmit a message to the touch display 104 .
- the touch display may be configured to display a state of confirmation including confirmed, not confirmed, or error.
- the label on the infusate can also allow for determination of drug pedigree.
- the infusion device 100 can further transmit a message to an external device through the communication module 165 stating that identity is confirmed or not confirmed.
- the one or more identification sensors 185 can also be configured to confirm that the correct dosage is present in an infusate.
- the infusate may be labeled with an RF tag or bar code corresponding to the amount of dose present.
- the identification sensors 185 can detect the identity of the RF tag or bar code on the infusate and transmit that data to the computing module 160 .
- the computing module 160 can be configured to compare the amount of dose identified by the identification sensors 185 to information programmed into the infusion device 100 . If the amount of dose is not confirmed, the computing module 160 can be configured to prevent infusion from occurring. In response to confirming or not confirming the amount of dose, the computing module 160 can also be configured to transmit a message to the touch display 104 .
- the touch display 104 may be configured to display a state of confirmation including confirmed, not confirmed, or error.
- the infusion device 100 can further transmit a message to an external device through the communication module 165 stating that the amount of dose is confirmed or not confirmed.
- the identification sensors 185 may have a writing capability.
- the identification sensors 185 may be configured to add, modify, or replace data on a label such as an RF tag or bar code.
- the RF tag can comprise an NFC type RF tag.
- the identification sensors 185 may comprise an optical bar code scanner.
- the infusion device 100 can be configured to monitor and detect predetermined events and characteristics associated with the use of an infusion device.
- the infusion device 100 may be configured to detect that an infusate is in condition for infusion prior to commencing infusion.
- the infusion sensors 190 can be configured to collect infusion parameter data including, but not limited to temperature, flow, and pressure.
- the air bubble detector 115 can be configured to detect the presence of air or other gases in a fluid.
- the infusion sensors 190 and the air bubble detector 115 are activated after the computing module 160 receives programed instructions.
- sensor data is transmitted from the infusion sensors 190 and the air bubble detector 115 to the computing module 160 .
- the computing module 160 then performs on-board processing using an algorithm to determine the state of the infusate.
- the computing module 160 determines whether one or more infusion parameters are outside of a defined range. If a determination is made that one or more infusion parameters are outside of a defined range, the computing module 160 may prevent infusion from occurring.
- the computing module 160 can further transmit data to the touch display 104 , and in response, the touch display 104 can display a state of the infusate.
- states of the infusate include, but are not limited to, ready for infusion, not ready, within range, outside of range, and error.
- the computing module 160 can also communicate the state of the infusate data to the communication module 165 , and in response, the communication module 165 can transmit the state of the infusate data to an external device.
- the one or more infusion sensors 190 and the air bubble detector 115 can further be configured to monitor infusion parameters throughout the administration of infusion.
- the infusion parameters can be monitored continuously until infusion is complete.
- the infusion sensors 190 and the air bubble detector 115 can be configured to monitor infusion parameters at defined intervals during infusion.
- the computing module 160 may terminate infusion or prevent infusion or further infusion from occurring in response to one or more predetermined events. For example, if a determination is made that one or more infusion parameters are outside of a defined range, the computing module 160 may terminate infusion and prevent further infusion from occurring. Other predetermined events include detection that a full dose has been administered based on the infusion parameters or detection that identification sensor data does not match the infusion parameters.
- the computing module 160 may further transmit data to the touch display 104 or to an external device using communication module 165 to provide notification of termination of infusion.
- the one or more infusion sensors 190 can detect end of dose. After end of dose is determined, the sensors 190 can transmit end of dose data to the computing module 160 .
- the computing module 160 can transmit the end of dose data to the touch display 104 , and in response, the touch display can be configured to display that end of dose was achieved.
- the computing module 160 can further transmit the end of dose data to the communication module 165 .
- the communication module 165 can transmit the end of dose data to an external device.
- the one or more infusion sensors 190 can also detect the amount of infusate delivered to a patient. The amount of infusate data can then be transmitted to the touch display 104 or to an external device through the communication module 165 .
- the sensors 190 may comprise a temperature sensor.
- the temperature sensor can be used to verify cold-chain storage and distribution.
- the temperature sensor can be used to detect the ambient temperature when an infusion event occurs.
- the sensors 190 may comprise, an optical sensor including, but not limited to an IR sensor.
- the optical sensor can detect data relevant to end of dose.
- the one or more sensors 190 can detect dose administration speed.
- the sensors 190 may comprise a flow sensor.
- the flow sensor can detect dose administration speed.
- the sensors 190 may comprise a pressure sensor.
- the pressure sensor can measure the pressure in a disposable fluid path. This data can be relevant for calculating flow speed.
- the sensors 190 may comprise a Hall effect sensor.
- the Hall effect sensor can detect data relevant to end of dose.
- the sensors 190 may detect the type of infusate in the infusion device.
- the camera 175 of the infusion device 100 can further be configured to provide video communication to an external device.
- the camera 175 can be configured to record video.
- the microphone 180 can be configured to record sound.
- the camera 175 and microphone 180 can transmit video and audio data to the communication module 165 .
- the communication module 165 can transmit the video and audio data to an external device.
- the infusion device 100 can also be configured to receive video communication from an external device.
- the communication module 165 can receive video and audio data from an external device.
- the video data can be transmitted to the touch display 104 and the sound data can be transmitted to the microphone 180 .
- the touch display 104 can display the video corresponding to the video data and the microphone 180 can emit the sound corresponding to the sound data.
- the infusion device 100 can allow a patient to communication with a clinician, payer, or pharmacy through video communication.
- the infusion device 100 can be configured to provide for a solely audio communication.
- the communication module 165 can be connected to a network by wired or wireless communication, cell communication, Bluetooth®, ZigBee®, LAN, WLAN, RF, IR, or any other communication method or system known in the art.
- the communication module 165 can communicate with a mobile device, a home health monitor, a computer, a server, or any other external device. This allows device data to be transmitted to users, payers, pharmacists, physicians, nurses, family members or any other desired parties.
- the communication module 165 may be configured to perform short-distance RF communication, such as Bluetooth, BLE, or ZigBee®.
- the communication module 165 may also be configured to perform long distance wireless communication through cellular protocols such as 3G, 4G/LTE, or WiMax.
- the infusion device 100 can further comprise one or more ports or sockets to allow for a wired connection between the infusion device 100 and an external device such as a mobile device or computer. Data may further be transferred from the infusion device 100 to an external device using a data storage device such as a flash drive or memory card.
- a data storage device such as a flash drive or memory card.
- the communication module 165 may further be configured to communicate with the electronic medical records of a medical facility.
- the communication module 165 can transmit infusion data to the electronic medical records system.
- the communication module 165 can also be configured to receive patient data from the electronic medical records system, which can allow a user to ascertain an infusate and dosage to administer.
- the power module 155 can comprise a rechargeable battery.
- the power module 155 can include an external switch. The power module 155 can supply power to the infusion device for multiple hours.
- the location sensors 195 can be configured to determine the place and time of an infusion event.
- the location sensors 195 comprise GPS technology.
- the place and time data can be transmitted to an external device or stored in the memory 198 of the infusion device 100 .
- the memory 198 can be configured to store data including, but not limited to, programmed infusion instructions, infusion parameter data, identification parameter data, location and time data, verification of dose data, textual transmission data, video transmission data, and audio transmission data.
- the motion control module 170 and the motion actuation module 168 can be configured to regulate the motion of the infusion driving element 120 .
- the computing module 160 may further be configured to perform database querying and cross verification, digital counting, and integration of voltage and current signals to drive the infusion process.
- the infusion device 100 may further comprise software that provides an interface on the touch display 104 .
- the software can be packaged as an application or series of applications such as those used in portable consumer mobile devices.
- the application or series of applications can provide functionality to connect the pump to external devices, allowing for the transmission of data to electronic medical records, clinicians, pharmacies, and payers.
- the application can also provide for database querying and cross verification, digital counting, and the integration of voltage and current signals to drive the infusion process.
- an application can also be configured to provide for simple programming of the infusion device 100 .
- the touch display 104 can display a set of infusion related factors including, but not limited to, the identity of the patient, the fluid to be administered, amount of dose, rate of dose administration, and intervals at which the dose is to be administered.
- the application may then allow a user to input values for each factor.
- the user may input values by typing the corresponding letters and numbers using the touch display.
- the values may then be compared to a database, for example, of different potential infusates.
- the user may select the values from a list of values.
- a list of values may be updated wirelessly through the communication module 165 .
- FIG. 4 depicts a flowchart of one embodiment of a process operating an infusion device such as infusion device 100 depicted in FIGS. 1-3 .
- the process 400 begins at a start step, and then moves to a step 405 wherein an infusion device is programmed, such as infusion device 100 depicted in FIGS. 1-3 .
- the infusion device may be programmed using a touch display such as touch display 104 depicted in FIGS. 1-3 .
- the infusion device may be programmed remotely by transmitting instructions to a communication module, such as communication module 165 depicted in FIG. 3 .
- process 400 moves to a process step 410 , wherein identification specifications are confirmed by one or more identification sensors.
- identification specifications are confirmed by the process 400
- process 400 moves to a process step 415 , wherein sensor data is monitored by one or more infusion related sensors prior to infusion. The sensor data can be monitored to determine if one or more measurements are within programmed infusion parameters or safety parameters.
- process step 415 will be explained in further detail below with reference to FIG. 6 .
- the process 400 moves to a step 420 , wherein an infusion begins to be administered by the infusion device, such as infusion device 100 depicted in FIGS. 1-3 .
- the process 400 moves to a step 423 , wherein sensor data is obtained from one or more sensors in the infusion device, such as the infusion sensors 190 and the air bubble detector 115 depicted in FIG. 3 .
- the process 400 moves to a decision step 425 , wherein a determination is made whether sensor data from one or more of the sensors is within a defined range.
- the defined range for one or more of the sensors may be based on infusion parameters input by a user.
- the defined range for one or more of the sensors may also be based on preprogrammed safety parameters.
- the determination can be performed by a computing module, such as computing module 160 depicted in FIG. 3 .
- step 425 If a determination is made at decision step 425 that the sensor data for one or more of the sensors is not within a defined range, the process 400 moves to a step 430 , wherein error handling occurs.
- sensor data can be transmitted to an external device or to a display on the infusion device.
- a computing module such as computing module 160 depicted in FIG. 3 , may also terminate infusion and prevent further infusion from occurring until the sensor data is within a defined range.
- infusion data is transmitted to an external device through a communication module, such as communication module 165 depicted in FIG. 3 .
- the infusion data can also be transmitted to a display on the infusion device.
- the infusion data can include the sensor data from one or more sensors such as the infusion sensors 190 and air bubble detector 115 , identification information, time information, and amount of dosage information.
- a state of the infusate can be determined by a computing module. The determined state can then be transmitted to an external device or to the display.
- the process 400 moves to a decision step 440 , wherein a determination is made whether infusion continues to occur. This determination may be performed by one or more sensors including, but not limited to, an optical sensor or Hall effect sensor. If a determination is made that infusion continues to occur, the process 400 returns to step 423 to continue to obtain sensor data. If a determination is made at decision step 440 that infusion does not continue to occur, the process 400 concludes at an end step.
- FIG. 5 depicts a flowchart of a process 410 of an illustrative embodiment according to the present invention of confirming identification specifications.
- the process 410 begins at a start step, and then moves to a step 505 , wherein patient identification information is obtained.
- the patient identification can be performed by one or more identification sensors, such as identification sensors 180 depicted in FIG. 3 . Identification can also be performed using a camera, such as camera 175 depicted in FIGS. 1-3 .
- the process 410 moves to a decision step 510 , wherein a determination is made whether the patient identification information matches the patient information programmed to the infusion device. If a determination is made that the patient identification information does not match the programmed patient information, the process 410 moves to a step 515 , wherein error handling occurs.
- a notification may be transmitted to an external device or to a display on the infusion device, notifying that there was not a match. After the notification is transmitted, the process 410 returns to step 505 to continue to obtain patient identification information.
- the process 410 moves to a step 520 , wherein fluid identification information is obtained.
- the fluid identification can be performed by one or more identification sensors.
- the process 410 moves to a decision step 525 , wherein a determination is made whether the fluid identification information matches the fluid information programmed to the infusion device. The determination can be performed by a computing module such as computing module 160 depicted in FIG. 3 . If a determination is made that the fluid identification information does not match the programmed fluid information, the process 410 moves to a step 515 , wherein error handling occurs. At step 515 , a notification may be transmitted to an external device or to a display on the infusion device, notifying that there was not a match. After the notification is transmitted, the process 410 returns to step 505 to continue to obtain patient identification information.
- step 525 If a determination is made at step 525 that the fluid identification information matches the programmed fluid information, the process 410 moves to a step 530 , wherein dosage identification information is obtained. In this step, the amount of dose available is obtained.
- the dosage identification can be performed by one or more sensors.
- the process 410 moves to a decision step 535 , wherein a determination is made whether the dosage identification information matches the dosage information programmed to the infusion device. The determination can be performed by a computing module such as computing module 160 depicted in FIG. 3 . If a determination is made that the dosage identification information does not match the programmed dosage information, the process 410 moves to a step 515 , wherein error handling occurs. At step 515 , a notification may be transmitted to an external device or to a display on the infusion device, notifying that there was not a match. After the notification is transmitted, the process 410 returns to step 505 to continue to obtain patient identification information.
- step 535 If a determination is made at step 535 that the dosage identification information matches the programmed dosage information, the process 410 concludes at an end step.
- FIG. 6 depicts a flowchart of a process 415 of an illustrative embodiment according to the present invention of monitoring sensor data prior to infusion.
- the process 415 begins at a start step, and then moves to a step 605 , wherein sensor data is obtained from one or more sensors in the infusion device, such as the infusion sensors 190 and the air bubble detector 115 depicted in FIG. 3 .
- the process 415 then moves to a decision step 610 wherein a determination is made whether sensor data from one or more sensors of the sensors is within a defined range.
- the defined range for one or more of the sensors may be based on infusion parameters input by a user.
- the defined range for one or more of the sensors may also be based on preprogrammed safety parameters. If a determination is made that the sensor data from one or more of the sensors is within a defined range, the process 415 concludes at an end step.
- the process 415 moves to a step 615 , wherein error handling occurs.
- a notification may be transmitted to an external device or to a display on the infusion device, notifying that the sensor data is not within a defined range.
- the computing module may prevent an infusion from occurring, unless the sensor data is recalculated and the sensor data from one or more of the sensors is within the defined range.
- FIGS. 7A and 7B depict an alternate embodiment of an infusion device 700 in accordance with an illustrative embodiment of the invention.
- the infusion device 700 includes a housing sleeve 702 , a mobile device 703 and a pump head 710 .
- the housing sleeve 702 can be configured to house an infusion driving element, such as infusion driving element 120 depicted in FIG. 1 .
- the housing sleeve 702 may further comprise a pump head connection port 714 .
- the pump head 710 can be attached to a pump head connection (not shown) of an infusion driving element (not shown) through the pump connection port 714 .
- the housing sleeve 702 may further be configured to house an air bubble detector 715 .
- the housing sleeve may further comprise a connection module configured to connect the housing sleeve 702 to the mobile device 703 .
- the mobile device 703 may be comprise one or more of the modules and components included in the infusion device 100 as depicted in FIGS. 1-3 , such as a camera, a microphone, a touch display, a power module, a computing module, a communication module, one or more infusion sensors, one or more identification sensors, one or more location sensors, a memory, a motion control module, and a motion actuation module.
- the housing sleeve 702 is adapted to receive and mount the mobile device 703 .
- the housing sleeve 702 can be configured to provide a structural coupling between the infusion driving element and the mobile device 703 .
- the housing sleeve 702 is made of a flexible material to allow the portions of the sleeve that do not contain electrical components to bend or fold for easier transport of the housing sleeve 702 .
- the housing sleeve 702 can also contain rigid sections to provide protection for the driving element and air bubble detector, as well as the mobile device 703 .
- the housing sleeve 702 may further include one or more protrusions, ridges, recesses, curves, edges, lips, openings, rough surfaces, or other physical features to facilitate gripping of the infusion device 700 .
- the housing sleeve 702 may further be configured to engage with a cell phone holder or clip.
- the housing sleeve 702 is adapted to include openings for access to mobile device features including, but not limited to, buttons, keyboards, screens, interfaces, plugs, jacks, sockets, speakers, and cameras.
- the housing sleeve 702 is further adapted to include room for wires, cords, or other connection elements to the mobile device.
- connection module of the housing sleeve is connectable to the mobile device 703 .
- the connection module can include any wired or wireless mobile device connector known in the art, including, but not limited to USB, USB Mini-A, USB Mini-B, Micro-USB, 8-pin, 9-pin and 30-pin connectors, and electromagnetic couplings.
- the connection module includes any wireless connection module connectable to a mobile device known in the art, including, but not limited to, radio frequency, Bluetooth®, infrared, Wi-Fi or cellular connection modules.
- the connection module is adapted to provide electrical power from the mobile device 703 to the infusion driving element of the housing sleeve 702 .
- the connection module is further adapted to provide electrical power to the air bubble detector 715 from the mobile device 703 .
- the housing 702 may further comprise a controller interface (not shown).
- the controller interface can be adapted to receive a signal from the mobile device 703 through the connection module.
- the controller interface can translate digital or analog electrical signals input from the mobile device 703 through the connection module, into electric signals, including, but not limited to, digital or analog electrical signals output to the infusion driving element.
- the signals are indicative of instruction for a motor of the infusion driving element, including, but not limited to, a start command, a stop command, a direction command, and a speed command.
- the infusion device 700 can be configured to perform the same functions as described above with respect to infusion device 100 depicted in FIGS. 1-3 , including, but not limited to, programming of the infusion device 700 , confirming the identity of a patient, fluid, or dosage amount, detecting that a fluid is in condition for infusion and that infusion is properly occurring, preventing infusion from occurring if sensor data is not within defined parameters, detecting end of infusion, communicating data to an external device, recording a place, date, and time at which an infusion event occurs, and displaying data on a display of the infusion device 700 .
- Implementations disclosed herein provide systems, methods and apparatus for a smart portable infusion pump.
- One skilled in the art will recognize that these embodiments may be implemented in hardware, software, firmware, or any combination thereof.
- Disk and disc includes compact disc (CD), laser disc, optical disc, digital versatile disc (DVD), floppy disk and Blu-ray® disc where disks usually reproduce data magnetically, while discs reproduce data optically with lasers.
- a computer-readable medium may be tangible and non-transitory.
- the term “computer-program product” refers to a computing device or processor in combination with code or instructions (e.g., a “program”) that may be executed, processed or computed by the computing device or processor.
- code may refer to software, instructions, code or data that is/are executable by a computing device or processor.
- Software or instructions may also be transmitted over a transmission medium.
- a transmission medium For example, if the software is transmitted from a website, server, or other remote source using a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave, then the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, and microwave are included in the definition of transmission medium.
- DSL digital subscriber line
- the methods disclosed herein comprise one or more steps or actions for achieving the described method.
- the method steps and/or actions may be interchanged with one another without departing from the scope of the claims.
- the order and/or use of specific steps and/or actions may be modified without departing from the scope of the claims.
- Couple may indicate either an indirect connection or a direct connection.
- first component may be either indirectly connected to the second component or directly connected to the second component.
- plurality denotes two or more. For example, a plurality of components indicates two or more components.
- determining encompasses a wide variety of actions and, therefore, “determining” can include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Also, “determining” can include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory) and the like. Also, “determining” can include resolving, selecting, choosing, establishing and the like.
- examples may be described as a process, which is depicted as a flowchart, a flow diagram, a finite state diagram, a structure diagram, or a block diagram.
- a flowchart may describe the operations as a sequential process, many of the operations can be performed in parallel, or concurrently, and the process can be repeated. In addition, the order of the operations may be re-arranged.
- a process is terminated when its operations are completed.
- a process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc.
- a process corresponds to a software function
- its termination corresponds to a return of the function to the calling function or the main function.
Abstract
Described herein is a programmable portable infusion device. The infusion device may include electronics such as sensors, and can be programmed to detect parameters related to the proper administration of infusion. If the sensors detect that a parameter is outside of a defined boundary or range, the infusion device may notify a user that it may not be safe to administer infusion and may prevent infusion from occurring.
Description
- This application claims priority to U.S. Provisional Appl. No. 62/107,934 filed on Jan. 26, 2015, which is hereby incorporated by reference in its entirety.
- 1. Field of the Invention
- This invention relates to infusion pumps, and more particularly, relates to portable infusion pumps with smart capabilities for providing fluids to patients in need of therapeutic treatments.
- 2. Description of the Related Art
- Infusion pumps are medical devices that provide delivery of measured amounts of infusates, which are fluids such as medicine or nutrients, to a patient. Infusion pumps allow for delivery of precise volumes of fluids, including very small volumes, at precise intervals or rates. Infusion pumps currently on the market have programmable interfaces that allow for customizable therapeutic treatment regimens. Existing devices can store and retrieve drug libraries and have safeguards capable of preventing gross programming errors if ineffective or life-threatening infusion parameters are attempted for a particular drug. Existing infusion pumps may also connect to the electronic medical records system of the care facility in which they operate.
- However, the complexity of a typical infusion pump can make it difficult to use. Infusion pumps can be difficult to set up, to program, and to operate. For this reason, they generally require trained medical personnel to operate. Existing pumps also tend to be large and bulky, restricting the ability for a patient to leave a treatment area while continuing to receive care or from moving within a treatment area.
- One aspect of the invention is a smart programmable infusion device that contains a driving element of an infusion pump as well as a plurality of smart modules to detect a condition of use of the infusion pump and communicate that information to a patient.
- One embodiment is a device for confirming the identity of a patient, the identity of an infusate, or the dosage amount of an infusate. This aspect can be achieved by providing one or more identification sensors.
- Another embodiment of the present invention is a device for preventing infusion if an infusate is not in suitable condition for infusion or if the infusion is not being administered properly. This aspect can be achieved by providing one or more sensors related to conditions affecting the infusate or of the infusion process.
- Another embodiment is a method of operating a programmable infusion device comprising a plurality of smart modules.
- Another embodiment of the present invention is a method of detecting the identity of a patient, the identity of an infusate, or the dosage amount of an infusate.
- In another embodiment, data related to the identity of a patient, the identity of an infusate, or the dosage amount of an infusate can be transmitted to an external device.
- Another embodiment is a method of detecting the condition of use of an infusate and an infusion device.
- In another embodiment of the present invention, data related to the condition of use of an infusate or of an infusion device can be transmitted to an external device.
-
FIG. 1A depicts a front perspective view of an infusion device in accordance with an illustrative embodiment of the present invention. -
FIG. 1B depicts a rear perspective view of an infusion device in accordance with an illustrative embodiment of the present invention. -
FIG. 2 depicts a cut-away perspective view showing the interior of an infusion device in accordance with an illustrative embodiment of the present invention. -
FIG. 3 depicts a schematic view of an infusion device in accordance with an illustrative embodiment of the present invention. -
FIG. 4 depicts a flowchart of an embodiment of a method of operating an infusion device in accordance with an illustrative embodiment of the present invention. -
FIG. 5 depicts a flowchart of an embodiment of confirming identification parameters in an infusion device in accordance with an illustrative embodiment of the present invention. -
FIG. 6 depicts a flowchart of an embodiment of monitoring sensor parameters in an infusion device in accordance with an illustrative embodiment of the present invention. -
FIG. 7A depicts an infusion device in accordance with an illustrative embodiment of the present invention. -
FIG. 7B depicts an infusion device in accordance with an illustrative embodiment of the present invention. - As will be appreciated by one skilled in the art, there are numerous ways of carrying out the examples, improvements, and arrangements of an infusion device in accordance with embodiments of the invention disclosed herein. Although reference will be made to the illustrative embodiments depicted in the drawings and the following description, these embodiments are not meant to be exhaustive of the various alternative designs and embodiments that are encompassed by the disclosed invention. Those skilled in the art will readily appreciate that various modifications may be made, and various combinations can be made, without departing from the invention.
- One embodiment of the invention is an intelligent portable infusion device that includes an integrated infusion pump in a lightweight and handheld form factor. The infusion pump may be made up of a driving element and an infusion pump head, as described in more detail below. In one embodiment, the infusion pump is a volumetric infusion pump. Such pumps may be used, among other applications, to treat patients undergoing chemotherapy.
- In one embodiment, the infusion device is made of two principle components, one being a smart device such as a cellular telephone, and the other being an infusion device that is configured to pump fluids. In this embodiment, the cellular telephone may mate with the infusion device and run applications allowing the cellular telephone to control the operation of the infusion device. In one embodiment, the infusion device is a cradle that is adapted to electrically and mechanically mate with a cellular telephone. A user may then control the infusion device by inputting commands to a touch screen of the cellular telephone to thereby control the operation of the infusion device. The infusion device may include a supplemental battery to extend the useful operating time of the cellular telephone while connected to the infusion device.
- In one embodiment, the infusion device may have a portable durable housing that contains a touch screen or other user interface control system for inputting and monitoring the operation of the device. Including all of the elements of an intelligent infusion pump in a small portable device allows medicament infusion to be readily administered at a medical facility, in the home, or in an ambulatory setting. The infusion device can also allow freedom of movement for a patient undergoing an infusion. The infusion device may be reusable, allowing for a clinician or emergency medical technician to treat multiple patients using the same pump.
- In one illustrative embodiment, the portable durable housing contains the driving element of an intelligent infusion pump, as well as a plurality of smart modules and sensors. The portable durable housing can be configured to engage a pump head, the pump head being configured to further engage a disposable fluid path. The driving element in the portable durable housing can be configured to cause motion in the pump head, displacing fluid within the disposable fluid path. In one embodiment, the pump head may be disposable, allowing for multiple pump heads to be used with the same infusion device. The disposable feature of the pump head can decrease the risk of contamination when administering multiple fluids to multiple patients. The pump head may further be packaged as part of the disposable fluid head to allow for easy assembly and use of the infusion device. Furthermore, the driving element of the infusion device may be configured to engage and drive multiple types of pump heads.
- In some embodiments, the infusion device is configured to be programmable by a user. Infusion pumps provide the delivery of a measured amount of infusates. The infusion device can comprise a user interface displayed on a touch screen for programming one or more infusion parameters. These parameters can include the fluid to be administered, amount of dose, rate of dose administration, and intervals at which the dose is to be administered. In one illustrative embodiment, the infusion device further comprises a computing module containing one or more microprocessors that receive programmed instructions from the user interface or from an external device and can transmit those instructions to the infusion driving element so that an infusion is administered according to the programmed instructions.
- In an illustrative embodiment, the infusion device can include one or more environmental sensors capable of monitoring and detecting external events or characteristics associated with the use of the infusion device. Exemplary environmental sensors can be configured to measure temperature, flow, pressure, and the presence of air in fluid. The sensors may detect a state of a fluid being administered to a user. The smart device can also include a computing module configured to process data from the sensors to determine a state of the fluid being administered. Thus, the smart device can verify cold chain and drug authenticity. Once the state of the fluid is determined, the computing module may determine if the fluid is ready for infusion to a patient. If the fluid is not ready for infusion, the device can be configured with safeguards to prevent the administration of infusion if the fluid is not ready for use, or if the device is programmed to deliver a dangerous or ineffective amount of fluid.
- The infusion device may further include one or more identification sensors including, but not limited to, a digital camera, a radio frequency (RF) tag reader and a bar code scanner. In some instances, the same infusion device may be used for more than one patient or more than one fluid. The identification sensors can be configured to ascertain the identity of the infusate being administered by the infusion device. If the correct infusate is not identified by the identification sensor, the infusion device may be configured to prevent administration of the infusate. An identifier, such as a bar code or RF tag can also contain dosage information. Thus, the identification sensors may also be configured to identify the dosage of the medicine about to be delivered to the user. If the correct dose is not identified by the identification sensor, the infusion device may be configured to prevent administration of the fluid.
- In some embodiments, the infusion device can be configured to prevent infusion, terminate infusion, or prevent further infusion based on the occurrence of one or more predetermined events, such as, for example, determination that data from one or more environmental sensors is outside of a defined range, determination from one or more identification sensors that a correct patient, a correct infusate, or a correct dosage has not been identified, and determination that a full dosage has been administered to a patient.
- Furthermore, an identifier, such as a bar code or RF tag can include information about the origin of an infusate, the transportation of an infusate, and any transactions involving the infusate. Thus, the identification sensors may further be configured to confirm drug pedigree. In a clinical setting, medical personnel may use the same device for more than one user. An identifier, such as a bar code or RF tag may be attached to a patient. The identification sensor can be configured to identify a particular patient. If the intended patient is not identified, the smart device may be configured to prevent administration of the fluid. In one embodiment, the device may include a camera and perform facial recognition to identify the authorized user. An application running on the infusion device can direct a user to take a facial picture using the camera. The application can further provide visual indicators on a touch display to assist the user in aligning their face with the camera. The user may then take a facial picture, which can be transmitted to the computing module of the infusion device. At the computing module, the facial picture can be compared to a database of patient pictures stored in a memory of the infusion device. Alternatively, the facial picture may be transmitted to an external device or server containing a database of patient pictures for comparison.
- The infusion device may further include a communication module to allow for connectivity between the infusion device and external devices. This allows information from the infusion device to be transmitted to interested parties including the patient, payers, pharmacies and clinicians. The communication module may be configured to perform short-distance RF communication, such as Bluetooth, BLE, or ZigBee®. The communication module may also be configured to perform long distance wireless communication through cellular protocols such as 3G, 4G/LTE, or WiMax. The communication module may also be configured to automatically connect with the electronic medical records system of a user's care facility. The communication module may also allow a user to engage in real-time communication with a clinician. The infusion device may allow for instant messaging, telephonic communications, or real-time video communication. The infusion device can further be configured to store contact information including phone numbers, e-mail addresses, and instant messaging addresses of clinicians, pharmacies, and emergency services in the memory of the infusion device. The infusion device may further include a location sensor, which can be used to allow a user to contact the nearest emergency services provider.
- The infusion device may further include a camera. The camera can allow a user to take a picture or video of his or her face so that a clinician can positively identify the user. The camera may also allow a user to engage in a video conversation with a physician. The physician may then provide treatment or device usage advice to the user and answer any questions the user presents in the course of treatment. The camera may also perform facial recognition to identify and authenticate a user before the system allows the pump to be activated. Similarly, a fingerprint sensor or other input component on the infusion device may be used for authentication. An application running on the infusion device may direct the user to align their finger with one or more visual indicators on the touch display. The infusion device may capture the fingerprint and transmit the fingerprint data to the computing module of the infusion device or to an external device or server. The fingerprint can then be compared to a database of fingerprints to determine if there is a match. Furthermore, various forms of password protection may be utilized to prevent access to the infusion device, including textual and motion based passwords.
- The infusion device may further be configured to provide various notifications to a user. The notifications can relate to confirmation of identity, the state of an infusate, the state of an infusion, and the receipt of communication. The notifications can comprise visual notification on the touch display, auditory notification such as a chirp or beep, or tactile notification such as vibration of the infusion device. Although various persons, including, but not limited to, a patient or a healthcare professional, can operate or use illustrative embodiments of the present invention, for brevity an operator, patient or user will be referred to as a “user” hereinafter.
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FIGS. 1A and 1B depict a front and rear view of an illustrative embodiment of aninfusion device 100. Theinfusion device 100 includes arectangular housing 102 that is shaped to hold components of theinfusion device 100. Positioned on a front face of thehousing 102 is atouch display 104 that allows a user to enter commands to theinfusion device 100. Thetouch display 104 can use any well-known technology for registering single or multiple touch events and performing predetermined actions based on each touch. The housing also includes adigital camera 175 mounted centrally above thetouch display 104 and configured to capture digital images. - Along a lower portion of the
housing 102 are the pump components, including a cylindricalinfusion pump head 110. Thepump head 110 mounts to theinfusion device 100 through a pumphead connection port 114. Thepump head 110 also includes a pair offluid path connectors 112A,B which are configured to mate with tubing that contains the liquid to be pumped. - Also provided along the lower portion of the
housing 102, and adjacent the pumphead connection port 114 is anair bubble detector 115. - As shown, the
touch display 104, thecamera 175, the pump head connection port, and theair bubble detector 115 are located within thehousing 102. In some embodiments thehousing 102 may comprise a durable material such as plastic or metal. In some embodiments, thehousing 102 may be designed to be ergonomically comfortable for the user. In other embodiments, thehousing 102 may also include handgrips. - In an illustrative embodiment, a disposable fluid path is aligned to engage with the fluid path connecters 112A,B and the
air bubble detector 115. The disposable fluid path may comprise two or more sections of flexible tubing. A section of flexible tubing can extend from the source of the fluid and engagefluid path connector 112A. Another section of flexible tubing can engage fluid path connecter 112B and can be inserted intoair bubble detector 115. The other end of the flexible tubing engaged withfluid path connecter 112B can lead to a patient undergoing an infusion treatment. - In an illustrative embodiment, the
pump head 110 can comprise a positive displacement pump head, such as a rotary pump head or reciprocating motion based displacement pump head. However, it should be recognized that thepump head 110 is not limited to a rotary pump head, but may comprise any pump head known in the art. - In practice, the
pump head 110 would be activated, which would then cause fluid to move along the tubing. The fluid moves from the source of fluid to fluid path connecter 112A. The fluid then enters thepump head 110. Next, fluid is driven by thepump head 110 out offluid path connecter 112B. The fluid then traverses the flexible tubing connected to fluid path connecter 112B through theair bubble detector 115 and towards the patient. - In one embodiment, the
pump head 110 may be removable from thehousing 102. Thepump head 110 can thereby be configured to work with multiple infusion devices. - Alternatively, the
pump head 100 can be disposable. In one embodiment, a driving element can be configured to engage multiple types of pump heads. Thehousing 102, and all elements incorporated within thehousing 102, can be repeatedly used with multiple patients and multiple infusates. In some embodiments, thepump head 110 may come integrated within a disposable fluid path, the entirety of which may then engage with the infusion device in order to administer an infusion. - The
air bubble detector 115 may comprise, but is not limited to, an ultrasonic air bubble detector. Theinfusion device 100 may be configured to prevent the administration of fluid if an air bubble is detected in the fluid path byair bubble detector 115. Theair bubble detector 115 may also comprise one or more infusion-related sensors. The one or more infusion related sensors can comprise, but are not limited to, a temperature sensor, motion sensor, optical sensor, Hall effect sensor, flow sensor, and a pressure sensor. - In an illustrative embodiment, the
camera 175 can be configured to obtain pictures or video. For example, a picture may be taken of a patient to confirm identity. Video may be used to allow a patient to send a video communication to another party such as a clinician, payer, or pharmacy. - It should be realized that the
touch display 104 is configurable to allow for programming of theinfusion device 100. Thetouch display 104 can be used to enter a dosage amount, intervals at which doses should occur, or a rate at which an infusate is administered to a patient. Thetouch display 104 can also display information to a user related to the condition of the infusate or the state of the infusion event. This information can be detected by one or more infusion-related sensors or identification sensors housed in the interior of theinfusion device 100. The information can include, but is not limited to, temperature, pressure, end of dose, rate of dose, presence of air in fluid path, identity of drug, dosage amount of drug, identity of patient, time of infusion, and location of infusion. Thetouch display 104 may also be configured to allow a user to transmit information from the sensors to other parties including, but not limited to, clinicians, payers, or pharmacies. - The
touch display 104 may also be configured to allow a user to communicate with an external device. Thetouch display 104 can be configured to allow a user to input textual information to transmit that information to an external device. Thetouch display 104 can further be configured to allow a user to perform database querying by inputting textual information. Thetouch display 104 may also allow a user to open and view textual communications received from another party. Thetouch display 104 may also be configured to allow a user to initiate, control, and terminate an audio conversation, video conversation, or real-time textual conversation with another party. In the case of a video conversation, thetouch display 104 may display the video received from another party. In one embodiment of the present invention, thetouch display 104 may be configured to allow a user to operate thecamera 175, to view images obtained usingcamera 175, and to transmit those images to an external device. - It should be recognized that the
touch display 104 is not limited to a touch display, but may comprise any input and display mechanism known in the art. In an illustrative embodiment according to the present invention,touch display 104 may comprise a keyboard and a display screen. In another embodiment, thetouch display 104 may comprise a display screen and the operation performed on the screen may be voice controlled. Thetouch display 104, may include multiple methods of input, including, but not limited to, touch screen, keyboard, and voice control. Theinfusion device 100 may further include an orientation sensor. The infusion device can be configured to perform specified functions in response to the orientation or movement of the infusion device. -
FIG. 2 depicts the interior of aninfusion device 100 in accordance with an illustrative embodiment of the present invention. As shown inFIG. 2 , theinfusion device 100 includes thehousing 102, aninfusion driving element 120, thepump head 110, theair bubble detector 115, and anelectronics package 127. - The driving
element 120 includes amotor 122. The motor can comprise any electric motor known in the art, including, but not limited to, a brushed direct current (DC) electric motor, a brushless motor, a stepper motor, a servomotor, a gearmotor, a hollow shaft motor, or a shaftless motor. The drivingelement 120 further includes ashaft 124 and apump head connection 126 - In operation, when the
motor 122 is actuated, the drivingelement 120 causes rotary or reciprocal motion within thepump head 110. The rotary or reciprocal motion within thepump head 110 causes the displacement of fluid along a disposable fluid path. - The
electronics package 127 may comprise one or more infusion-related sensors, one or more identification sensors, a power module, a communication module, a computing module, a location module, and a memory. -
FIG. 3 depicts a schematic view of theinfusion device 100. Theinfusion device 100 comprises thehousing 102, theinfusion driving element 120, thepump head 110, thecamera 175, amicrophone 180, thetouch display 104, the air bubble detector and theelectronics package 127. Theinfusion driving element 120 further comprises themotor 122, theshaft 124, and thepump head connection 126. Theelectronics package 127 further comprises apower module 155, acomputing module 160, acommunication module 165, amotion actuation module 168, amotion control module 170, one ormore identification sensors 185, one ormore infusion sensors 190, alocation module 195, and amemory 198. Thecomputing module 160 may contain one or more microprocessors. - The
housing 102 houses theinfusion driving element 120, thecamera 175, themicrophone 180, thetouch display 104, theair bubble detector 115, and theelectronics package 127. Thepump head 110 engages thepump head connection 126 of theinfusion driving element 120. - The
infusion driving element 120, thepump head 110, thecamera 175, themicrophone 180, thetouch display 104, theair bubble detector 115, theinfusion sensors 190, theidentification sensors 185, thelocation sensors 195, themotion control module 170, and themotion actuation module 168 are in communication with thecomputing module 160. Thecomputing module 160 is further in communication with thememory 198 and thecommunication module 165. - The
housing 102 may comprise one or more pieces that can separately, partially or fully enclose one or more of theinfusion driving element 120, thepump head 110, thecamera 175, themicrophone 180, thetouch display 104, theair bubble detector 115, and theelectronics package 127. In an illustrative embodiment, thehousing 102 can be adapted to include openings for access to features of the infusion device including, but not limited to, thetouch display 104, thecamera 175, themicrophone 180, theair bubble detector 115, buttons, keyboards, screens, interfaces, plugs, jacks, sockets, and speakers. Thehousing 102 may be further adapted to include room for wires, cords, or any other connection elements that may be attached to theinfusion device 100. - In operation, the
infusion device 100 allows for the programming of the infusion device using thetouch display 104. A user can input a plurality of infusion parameters including, but not limited to, fluid to be administered, amount of dose, rate of dose administration, and intervals at which the dose is to be administered. In response, the programmed data is transmitted to thecomputing module 160. Thecomputing module 160 then performs on-board processing to determine if the programmed infusion parameters are within a safe and effective range. If the programmed parameters are within a safe and effective range, the device may be ready for infusion. - In some embodiments, the infusion device will commence infusion when it is found that the programmed parameters are within a safe and effective range. The
computing module 160 can transmit a signal indicative of instructions to themotor 122 of theinfusion driving element 120. The instructions can include, but are not limited to, a start command, a stop command, a direction command, and a speed command. In response, theinfusion element 120 can administer infusion in accordance with the programmed parameters. - In other embodiments, a notification may be transmitted to the
touch display 104 stating that the programmed parameters are acceptable, and then a further step must be taken to initiate infusion. For example, a button on thetouch display 104 can be engaged to initiate infusion. Theinfusion device 100 can also be configured to allow for programming from an external device. In operation, an external device can transmit programming data to thecommunication module 165. Thecommunication module 165 can then transmit the programming data to thecomputing module 160. In an illustrative embodiment, the infusion device can also be configured to allow for programming using themicrophone 180. Themicrophone 180 can transmit audio data to thecomputing module 160. Thecomputing module 160 may contain speech recognition software. Thecomputing module 160 may then translate the audio data in to programmed parameters. - The
touch display 104 can also be configured to provide for the transmission of data to an external device. For example, a textual message can be entered using thetouch display 104. The textual message can then be transmitted to thecommunication module 165. After receiving the textual message, thecommunication module 165 can be configured to transmit the textual message to an external device. Thetouch display 104 can also be configured to display data transmitted from an external device and received at thecommunication module 165. - The
identification sensors 185 can include, but are not limited to an RF tag reader or a bar code scanner. A care facility may attach an RF tag or bar code to a patient on, for example, a wristband. Theidentification sensors 185 can detect the identity of the RF tag or bar code on a patient and transmit that data to thecomputing module 160. Thecomputing module 160 can be configured to compare the identification information from theidentification sensors 185 to information programmed into theinfusion device 100. If the identity of the patient is not confirmed, thecomputing module 160 can be configured to prevent infusion from occurring. In response to confirming or not confirming the identity of a patient, thecomputing module 160 can also be configured to transmit a message to thetouch display 104. The touch display may be configured to display a state of confirmation including confirmed, not confirmed, or error. In an illustrative embodiment, theinfusion device 100 can further transmit a message to an external device through thecommunication module 165 stating that identity is confirmed or not confirmed. - In an illustrative embodiment according to the present invention, the
infusion device 100 can be configured to confirm the identity of the patient prior to commencing infusion. For example, one ormore identification sensors 185 can be configured to confirm the identity of a patient. In an illustrative embodiment, thecamera 175 may also be configured to confirm the identity of a patient. Thecamera 175 can capture picture or video of a patient. The image data captured by thecamera 175 can be transmitted to thecomputing module 160. Thecomputing module 160 can be configured to perform on-board processing to determine if the image data captured by the camera matches an image of the patient in a database. If the identity of the patient is not confirmed, thecomputing module 160 can be configured to prevent infusion from occurring. In an alternative embodiment, the image data can be transmitted to thecommunication module 165. From thecommunication module 165, the image data can be transmitted to an external device. In an illustrative embodiment, the image data is transmitted to a treating clinician who will confirm the identity of the patient. Alternatively, the image data can be compared to an image of a patient in a database at the external device. In response to confirming or not confirming the identity of a patient, thecomputing module 160 can also be configured to transmit a message to thetouch display 104. The touch display may be configured to display a state of confirmation including confirmed, not confirmed, or error. - In an illustrative embodiment the one or
more identification sensors 185 can also be configured to confirm the identity of an infusate. An infusate may be labeled with an RF tag or bar code. Theidentification sensors 185 can detect the identity of the RF tag or bar code on the infusate and transmit that data to thecomputing module 160. Thecomputing module 160 can be configured to compare the identification information from theidentification sensors 185 to information programmed into theinfusion device 100. If the identity of the infusate is not confirmed, thecomputing module 160 can be configured to prevent infusion from occurring. In response to confirming or not confirming the identity of an infusate, thecomputing module 160 can also be configured to transmit a message to thetouch display 104. The touch display may be configured to display a state of confirmation including confirmed, not confirmed, or error. The label on the infusate can also allow for determination of drug pedigree. In an illustrative embodiment, theinfusion device 100 can further transmit a message to an external device through thecommunication module 165 stating that identity is confirmed or not confirmed. - In an illustrative embodiment the one or
more identification sensors 185 can also be configured to confirm that the correct dosage is present in an infusate. The infusate may be labeled with an RF tag or bar code corresponding to the amount of dose present. Theidentification sensors 185 can detect the identity of the RF tag or bar code on the infusate and transmit that data to thecomputing module 160. Thecomputing module 160 can be configured to compare the amount of dose identified by theidentification sensors 185 to information programmed into theinfusion device 100. If the amount of dose is not confirmed, thecomputing module 160 can be configured to prevent infusion from occurring. In response to confirming or not confirming the amount of dose, thecomputing module 160 can also be configured to transmit a message to thetouch display 104. Thetouch display 104 may be configured to display a state of confirmation including confirmed, not confirmed, or error. In an illustrative embodiment, theinfusion device 100 can further transmit a message to an external device through thecommunication module 165 stating that the amount of dose is confirmed or not confirmed. - In an illustrative embodiment according to the present invention, the
identification sensors 185 may have a writing capability. Theidentification sensors 185 may be configured to add, modify, or replace data on a label such as an RF tag or bar code. In one embodiment, the RF tag can comprise an NFC type RF tag. In another embodiment theidentification sensors 185 may comprise an optical bar code scanner. - The
infusion device 100 can be configured to monitor and detect predetermined events and characteristics associated with the use of an infusion device. For example, theinfusion device 100 may be configured to detect that an infusate is in condition for infusion prior to commencing infusion. Thus, theinfusion sensors 190 can be configured to collect infusion parameter data including, but not limited to temperature, flow, and pressure. Theair bubble detector 115 can be configured to detect the presence of air or other gases in a fluid. - In one embodiment, the
infusion sensors 190 and theair bubble detector 115 are activated after thecomputing module 160 receives programed instructions. In response, sensor data is transmitted from theinfusion sensors 190 and theair bubble detector 115 to thecomputing module 160. Thecomputing module 160 then performs on-board processing using an algorithm to determine the state of the infusate. In one embodiment, thecomputing module 160 determines whether one or more infusion parameters are outside of a defined range. If a determination is made that one or more infusion parameters are outside of a defined range, thecomputing module 160 may prevent infusion from occurring. Thecomputing module 160 can further transmit data to thetouch display 104, and in response, thetouch display 104 can display a state of the infusate. Examples of states of the infusate include, but are not limited to, ready for infusion, not ready, within range, outside of range, and error. Thecomputing module 160 can also communicate the state of the infusate data to thecommunication module 165, and in response, thecommunication module 165 can transmit the state of the infusate data to an external device. - The one or
more infusion sensors 190 and theair bubble detector 115 can further be configured to monitor infusion parameters throughout the administration of infusion. The infusion parameters can be monitored continuously until infusion is complete. Alternatively, theinfusion sensors 190 and theair bubble detector 115 can be configured to monitor infusion parameters at defined intervals during infusion. Thecomputing module 160 may terminate infusion or prevent infusion or further infusion from occurring in response to one or more predetermined events. For example, if a determination is made that one or more infusion parameters are outside of a defined range, thecomputing module 160 may terminate infusion and prevent further infusion from occurring. Other predetermined events include detection that a full dose has been administered based on the infusion parameters or detection that identification sensor data does not match the infusion parameters. Thecomputing module 160 may further transmit data to thetouch display 104 or to an external device usingcommunication module 165 to provide notification of termination of infusion. - In one illustrative embodiment, the one or
more infusion sensors 190 can detect end of dose. After end of dose is determined, thesensors 190 can transmit end of dose data to thecomputing module 160. Thecomputing module 160 can transmit the end of dose data to thetouch display 104, and in response, the touch display can be configured to display that end of dose was achieved. Thecomputing module 160 can further transmit the end of dose data to thecommunication module 165. In response to receiving the end of dose data, thecommunication module 165 can transmit the end of dose data to an external device. - In one illustrative embodiment, the one or
more infusion sensors 190 can also detect the amount of infusate delivered to a patient. The amount of infusate data can then be transmitted to thetouch display 104 or to an external device through thecommunication module 165. - In an illustrative embodiment according to the present invention, the
sensors 190 may comprise a temperature sensor. In one embodiment, the temperature sensor can be used to verify cold-chain storage and distribution. In one embodiment, the temperature sensor can be used to detect the ambient temperature when an infusion event occurs. - In an illustrative embodiment, the
sensors 190 may comprise, an optical sensor including, but not limited to an IR sensor. The optical sensor can detect data relevant to end of dose. In another embodiment, the one ormore sensors 190 can detect dose administration speed. - In an illustrative embodiment, the
sensors 190 may comprise a flow sensor. The flow sensor can detect dose administration speed. - In an illustrative embodiment, the
sensors 190 may comprise a pressure sensor. The pressure sensor can measure the pressure in a disposable fluid path. This data can be relevant for calculating flow speed. - In an illustrative embodiment, the
sensors 190 may comprise a Hall effect sensor. The Hall effect sensor can detect data relevant to end of dose. - In an illustrative embodiment, the
sensors 190 may detect the type of infusate in the infusion device. - In an illustrative embodiment, the
camera 175 of theinfusion device 100 can further be configured to provide video communication to an external device. Thecamera 175 can be configured to record video. Themicrophone 180 can be configured to record sound. Thecamera 175 andmicrophone 180 can transmit video and audio data to thecommunication module 165. Thecommunication module 165 can transmit the video and audio data to an external device. - The
infusion device 100 can also be configured to receive video communication from an external device. Thecommunication module 165 can receive video and audio data from an external device. The video data can be transmitted to thetouch display 104 and the sound data can be transmitted to themicrophone 180. Thetouch display 104 can display the video corresponding to the video data and themicrophone 180 can emit the sound corresponding to the sound data. Thus, theinfusion device 100 can allow a patient to communication with a clinician, payer, or pharmacy through video communication. In one alternative embodiment, theinfusion device 100 can be configured to provide for a solely audio communication. - The
communication module 165 can be connected to a network by wired or wireless communication, cell communication, Bluetooth®, ZigBee®, LAN, WLAN, RF, IR, or any other communication method or system known in the art. Thecommunication module 165 can communicate with a mobile device, a home health monitor, a computer, a server, or any other external device. This allows device data to be transmitted to users, payers, pharmacists, physicians, nurses, family members or any other desired parties. Thecommunication module 165 may be configured to perform short-distance RF communication, such as Bluetooth, BLE, or ZigBee®. Thecommunication module 165 may also be configured to perform long distance wireless communication through cellular protocols such as 3G, 4G/LTE, or WiMax. Theinfusion device 100 can further comprise one or more ports or sockets to allow for a wired connection between theinfusion device 100 and an external device such as a mobile device or computer. Data may further be transferred from theinfusion device 100 to an external device using a data storage device such as a flash drive or memory card. - The
communication module 165 may further be configured to communicate with the electronic medical records of a medical facility. Thecommunication module 165 can transmit infusion data to the electronic medical records system. Thecommunication module 165 can also be configured to receive patient data from the electronic medical records system, which can allow a user to ascertain an infusate and dosage to administer. - In an illustrative embodiment according to the present invention, the
power module 155 can comprise a rechargeable battery. In one embodiment, thepower module 155 can include an external switch. Thepower module 155 can supply power to the infusion device for multiple hours. - In an illustrative embodiment according to the present invention, the
location sensors 195 can be configured to determine the place and time of an infusion event. In one embodiment, thelocation sensors 195 comprise GPS technology. The place and time data can be transmitted to an external device or stored in thememory 198 of theinfusion device 100. - In an illustrative embodiment according to the present invention, the
memory 198 can be configured to store data including, but not limited to, programmed infusion instructions, infusion parameter data, identification parameter data, location and time data, verification of dose data, textual transmission data, video transmission data, and audio transmission data. - In an illustrative embodiment according to the present invention, the
motion control module 170 and themotion actuation module 168 can be configured to regulate the motion of theinfusion driving element 120. - The
computing module 160 may further be configured to perform database querying and cross verification, digital counting, and integration of voltage and current signals to drive the infusion process. - The
infusion device 100 may further comprise software that provides an interface on thetouch display 104. The software can be packaged as an application or series of applications such as those used in portable consumer mobile devices. The application or series of applications can provide functionality to connect the pump to external devices, allowing for the transmission of data to electronic medical records, clinicians, pharmacies, and payers. The application can also provide for database querying and cross verification, digital counting, and the integration of voltage and current signals to drive the infusion process. - An application can also be configured to provide for simple programming of the
infusion device 100. In an illustrative embodiment, thetouch display 104 can display a set of infusion related factors including, but not limited to, the identity of the patient, the fluid to be administered, amount of dose, rate of dose administration, and intervals at which the dose is to be administered. The application may then allow a user to input values for each factor. The user may input values by typing the corresponding letters and numbers using the touch display. The values may then be compared to a database, for example, of different potential infusates. Alternatively, the user may select the values from a list of values. A list of values may be updated wirelessly through thecommunication module 165. -
FIG. 4 depicts a flowchart of one embodiment of a process operating an infusion device such asinfusion device 100 depicted inFIGS. 1-3 . Theprocess 400 begins at a start step, and then moves to astep 405 wherein an infusion device is programmed, such asinfusion device 100 depicted inFIGS. 1-3 . In one embodiment, the infusion device may be programmed using a touch display such astouch display 104 depicted inFIGS. 1-3 . In an alternative embodiment, the infusion device may be programmed remotely by transmitting instructions to a communication module, such ascommunication module 165 depicted inFIG. 3 . - After the device is programmed, the
process 400 moves to aprocess step 410, wherein identification specifications are confirmed by one or more identification sensors. The functions ofprocess step 410 will be explained in further detail below with reference toFIG. 5 . After the identification specifications are confirmed, theprocess 400 moves to aprocess step 415, wherein sensor data is monitored by one or more infusion related sensors prior to infusion. The sensor data can be monitored to determine if one or more measurements are within programmed infusion parameters or safety parameters. The function ofprocess step 415 will be explained in further detail below with reference toFIG. 6 . - After the sensor data has been monitored at
process step 415, theprocess 400 moves to astep 420, wherein an infusion begins to be administered by the infusion device, such asinfusion device 100 depicted inFIGS. 1-3 . - After the infusion begins to be administered, the
process 400 moves to astep 423, wherein sensor data is obtained from one or more sensors in the infusion device, such as theinfusion sensors 190 and theair bubble detector 115 depicted inFIG. 3 . - After the sensor data is obtained, the
process 400 moves to adecision step 425, wherein a determination is made whether sensor data from one or more of the sensors is within a defined range. The defined range for one or more of the sensors may be based on infusion parameters input by a user. The defined range for one or more of the sensors may also be based on preprogrammed safety parameters. The determination can be performed by a computing module, such ascomputing module 160 depicted inFIG. 3 . - If a determination is made at
decision step 425 that the sensor data for one or more of the sensors is not within a defined range, theprocess 400 moves to astep 430, wherein error handling occurs. In this step, sensor data can be transmitted to an external device or to a display on the infusion device. A computing module, such ascomputing module 160 depicted inFIG. 3 , may also terminate infusion and prevent further infusion from occurring until the sensor data is within a defined range. - If a determination is made at
decision step 425 that the sensor data for one or more of the sensors is within a defined range, then theprocess 400 moves to astep 435, wherein infusion data is transmitted to an external device through a communication module, such ascommunication module 165 depicted inFIG. 3 . The infusion data can also be transmitted to a display on the infusion device. The infusion data can include the sensor data from one or more sensors such as theinfusion sensors 190 andair bubble detector 115, identification information, time information, and amount of dosage information. In another embodiment, a state of the infusate can be determined by a computing module. The determined state can then be transmitted to an external device or to the display. - After transmitting infusion data, the
process 400 moves to adecision step 440, wherein a determination is made whether infusion continues to occur. This determination may be performed by one or more sensors including, but not limited to, an optical sensor or Hall effect sensor. If a determination is made that infusion continues to occur, theprocess 400 returns to step 423 to continue to obtain sensor data. If a determination is made atdecision step 440 that infusion does not continue to occur, theprocess 400 concludes at an end step. -
FIG. 5 depicts a flowchart of aprocess 410 of an illustrative embodiment according to the present invention of confirming identification specifications. Theprocess 410 begins at a start step, and then moves to astep 505, wherein patient identification information is obtained. The patient identification can be performed by one or more identification sensors, such asidentification sensors 180 depicted inFIG. 3 . Identification can also be performed using a camera, such ascamera 175 depicted inFIGS. 1-3 . - After obtaining patient identification information, the
process 410 moves to adecision step 510, wherein a determination is made whether the patient identification information matches the patient information programmed to the infusion device. If a determination is made that the patient identification information does not match the programmed patient information, theprocess 410 moves to astep 515, wherein error handling occurs. Atstep 515, a notification may be transmitted to an external device or to a display on the infusion device, notifying that there was not a match. After the notification is transmitted, theprocess 410 returns to step 505 to continue to obtain patient identification information. - If a determination is made at
decision step 510 that the patient identification information matches the programmed patient information, theprocess 410 moves to astep 520, wherein fluid identification information is obtained. The fluid identification can be performed by one or more identification sensors. - After obtaining fluid identification information, the
process 410 moves to adecision step 525, wherein a determination is made whether the fluid identification information matches the fluid information programmed to the infusion device. The determination can be performed by a computing module such ascomputing module 160 depicted inFIG. 3 . If a determination is made that the fluid identification information does not match the programmed fluid information, theprocess 410 moves to astep 515, wherein error handling occurs. Atstep 515, a notification may be transmitted to an external device or to a display on the infusion device, notifying that there was not a match. After the notification is transmitted, theprocess 410 returns to step 505 to continue to obtain patient identification information. - If a determination is made at
step 525 that the fluid identification information matches the programmed fluid information, theprocess 410 moves to astep 530, wherein dosage identification information is obtained. In this step, the amount of dose available is obtained. The dosage identification can be performed by one or more sensors. - After obtaining fluid identification information, the
process 410 moves to adecision step 535, wherein a determination is made whether the dosage identification information matches the dosage information programmed to the infusion device. The determination can be performed by a computing module such ascomputing module 160 depicted inFIG. 3 . If a determination is made that the dosage identification information does not match the programmed dosage information, theprocess 410 moves to astep 515, wherein error handling occurs. Atstep 515, a notification may be transmitted to an external device or to a display on the infusion device, notifying that there was not a match. After the notification is transmitted, theprocess 410 returns to step 505 to continue to obtain patient identification information. - If a determination is made at
step 535 that the dosage identification information matches the programmed dosage information, theprocess 410 concludes at an end step. -
FIG. 6 depicts a flowchart of aprocess 415 of an illustrative embodiment according to the present invention of monitoring sensor data prior to infusion. Theprocess 415 begins at a start step, and then moves to astep 605, wherein sensor data is obtained from one or more sensors in the infusion device, such as theinfusion sensors 190 and theair bubble detector 115 depicted inFIG. 3 . Theprocess 415 then moves to adecision step 610 wherein a determination is made whether sensor data from one or more sensors of the sensors is within a defined range. The defined range for one or more of the sensors may be based on infusion parameters input by a user. The defined range for one or more of the sensors may also be based on preprogrammed safety parameters. If a determination is made that the sensor data from one or more of the sensors is within a defined range, theprocess 415 concludes at an end step. - If a determination is made that the sensor data from one or more sensors of the sensors is not within a defined range, the
process 415 moves to astep 615, wherein error handling occurs. Atstep 615, a notification may be transmitted to an external device or to a display on the infusion device, notifying that the sensor data is not within a defined range. In one embodiment, the computing module may prevent an infusion from occurring, unless the sensor data is recalculated and the sensor data from one or more of the sensors is within the defined range. After error handling occurs, theprocess 415 concludes at an end step. -
FIGS. 7A and 7B depict an alternate embodiment of aninfusion device 700 in accordance with an illustrative embodiment of the invention. Theinfusion device 700 includes ahousing sleeve 702, amobile device 703 and apump head 710. Thehousing sleeve 702 can be configured to house an infusion driving element, such asinfusion driving element 120 depicted inFIG. 1 . Thehousing sleeve 702 may further comprise a pumphead connection port 714. Thepump head 710 can be attached to a pump head connection (not shown) of an infusion driving element (not shown) through thepump connection port 714. Thehousing sleeve 702 may further be configured to house anair bubble detector 715. The housing sleeve may further comprise a connection module configured to connect thehousing sleeve 702 to themobile device 703. - The
mobile device 703 may be comprise one or more of the modules and components included in theinfusion device 100 as depicted inFIGS. 1-3 , such as a camera, a microphone, a touch display, a power module, a computing module, a communication module, one or more infusion sensors, one or more identification sensors, one or more location sensors, a memory, a motion control module, and a motion actuation module. - In an illustrative embodiment according to the present invention, the
housing sleeve 702 is adapted to receive and mount themobile device 703. Thehousing sleeve 702 can be configured to provide a structural coupling between the infusion driving element and themobile device 703. - In one embodiment, the
housing sleeve 702 is made of a flexible material to allow the portions of the sleeve that do not contain electrical components to bend or fold for easier transport of thehousing sleeve 702. Thehousing sleeve 702 can also contain rigid sections to provide protection for the driving element and air bubble detector, as well as themobile device 703. Thehousing sleeve 702 may further include one or more protrusions, ridges, recesses, curves, edges, lips, openings, rough surfaces, or other physical features to facilitate gripping of theinfusion device 700. Thehousing sleeve 702 may further be configured to engage with a cell phone holder or clip. - In an illustrative embodiment according to the present invention, the
housing sleeve 702 is adapted to include openings for access to mobile device features including, but not limited to, buttons, keyboards, screens, interfaces, plugs, jacks, sockets, speakers, and cameras. In an illustrative embodiment according to the present invention, thehousing sleeve 702 is further adapted to include room for wires, cords, or other connection elements to the mobile device. - In an illustrative embodiment according to the present invention, the connection module of the housing sleeve is connectable to the
mobile device 703. The connection module can include any wired or wireless mobile device connector known in the art, including, but not limited to USB, USB Mini-A, USB Mini-B, Micro-USB, 8-pin, 9-pin and 30-pin connectors, and electromagnetic couplings. In one embodiment, the connection module includes any wireless connection module connectable to a mobile device known in the art, including, but not limited to, radio frequency, Bluetooth®, infrared, Wi-Fi or cellular connection modules. In an illustrated embodiment, the connection module is adapted to provide electrical power from themobile device 703 to the infusion driving element of thehousing sleeve 702. In an illustrated embodiment, the connection module is further adapted to provide electrical power to theair bubble detector 715 from themobile device 703. - In an illustrated embodiment according to the present invention, the
housing 702 may further comprise a controller interface (not shown). The controller interface can be adapted to receive a signal from themobile device 703 through the connection module. The controller interface can translate digital or analog electrical signals input from themobile device 703 through the connection module, into electric signals, including, but not limited to, digital or analog electrical signals output to the infusion driving element. In an illustrative embodiment, the signals are indicative of instruction for a motor of the infusion driving element, including, but not limited to, a start command, a stop command, a direction command, and a speed command. - The
infusion device 700 can be configured to perform the same functions as described above with respect toinfusion device 100 depicted inFIGS. 1-3 , including, but not limited to, programming of theinfusion device 700, confirming the identity of a patient, fluid, or dosage amount, detecting that a fluid is in condition for infusion and that infusion is properly occurring, preventing infusion from occurring if sensor data is not within defined parameters, detecting end of infusion, communicating data to an external device, recording a place, date, and time at which an infusion event occurs, and displaying data on a display of theinfusion device 700. - Implementations disclosed herein provide systems, methods and apparatus for a smart portable infusion pump. One skilled in the art will recognize that these embodiments may be implemented in hardware, software, firmware, or any combination thereof.
- The functions described herein may be stored as one or more instructions on a processor-readable or computer-readable medium. The term “computer-readable medium” refers to any available medium that can be accessed by a computer or processor. By way of example, and not limitation, such a medium may comprise RAM, ROM, EEPROM, flash memory, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer. Disk and disc, as used herein, includes compact disc (CD), laser disc, optical disc, digital versatile disc (DVD), floppy disk and Blu-ray® disc where disks usually reproduce data magnetically, while discs reproduce data optically with lasers. It should be noted that a computer-readable medium may be tangible and non-transitory. The term “computer-program product” refers to a computing device or processor in combination with code or instructions (e.g., a “program”) that may be executed, processed or computed by the computing device or processor. As used herein, the term “code” may refer to software, instructions, code or data that is/are executable by a computing device or processor.
- Software or instructions may also be transmitted over a transmission medium. For example, if the software is transmitted from a website, server, or other remote source using a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave, then the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, and microwave are included in the definition of transmission medium.
- The methods disclosed herein comprise one or more steps or actions for achieving the described method. The method steps and/or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is required for proper operation of the method that is being described, the order and/or use of specific steps and/or actions may be modified without departing from the scope of the claims.
- It should be noted that the terms “couple,” “coupling,” “coupled” or other variations of the word couple as used herein may indicate either an indirect connection or a direct connection. For example, if a first component is “coupled” to a second component, the first component may be either indirectly connected to the second component or directly connected to the second component. As used herein, the term “plurality” denotes two or more. For example, a plurality of components indicates two or more components.
- The term “determining” encompasses a wide variety of actions and, therefore, “determining” can include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Also, “determining” can include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory) and the like. Also, “determining” can include resolving, selecting, choosing, establishing and the like.
- The phrase “based on” does not mean “based only on,” unless expressly specified otherwise. In other words, the phrase “based on” describes both “based only on” and “based at least on.”
- In the foregoing description, specific details are given to provide a thorough understanding of the examples. However, it will be understood by one of ordinary skill in the art that the examples may be practiced without these specific details. For example, electrical components/devices may be shown in block diagrams in order not to obscure the examples in unnecessary detail. In other instances, such components, other structures and techniques may be shown in detail to further explain the examples.
- Headings are included herein for reference and to aid in locating various sections. These headings are not intended to limit the scope of the concepts described with respect thereto. Such concepts may have applicability throughout the entire specification.
- It is also noted that the examples may be described as a process, which is depicted as a flowchart, a flow diagram, a finite state diagram, a structure diagram, or a block diagram. Although a flowchart may describe the operations as a sequential process, many of the operations can be performed in parallel, or concurrently, and the process can be repeated. In addition, the order of the operations may be re-arranged. A process is terminated when its operations are completed. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. When a process corresponds to a software function, its termination corresponds to a return of the function to the calling function or the main function.
- The previous description of the disclosed implementations is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these implementations will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the implementations shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (21)
1. A device for delivery of fluid, comprising:
an infusion pump driving element;
a removable pump head connected to the driving element and capable of displacing fluid along a disposable fluid path;
a housing at least partially enclosing the infusion pump driving element;
a processor configured to read programmed infusion parameters, wherein the processor is further configured to activate the infusion pump driving element in accordance with the programmed infusion parameters; and
one or more environmental sensors, wherein the processor is further configured to read data from the environmental sensors and prevent infusion if a predetermined event occurs.
2. The device of claim 1 , wherein the removable pump head is designed to be a disposable pump head.
3. The device of claim 2 , wherein the pump head comprises attachment points for tubing.
4. The device of claim 1 , housing comprises a touchscreen configured to receive electronic input from a user.
5. The device of claim 1 , wherein the housing comprises a sleeve configured to mate with a cellular telephone.
6. The device of claim 1 , wherein the one or more environmental sensors are temperature, flow, pressure, or air sensors.
7. The device of claim 6 , wherein the one or more environmental sensors is an air sensor, wherein the air sensor is configured to detect the presence of air within tubing connected to the pump head.
8. The device of claim 7 , wherein the air sensor is mounted to the housing that encloses the infusion pump driving element.
9. The device of claim 1 , further comprising an identification sensor configured to identify a patient, an infusate, or the dosage amount of an infusate.
10. The device of claim 9 , wherein the identification sensor comprises a digital camera or fingerprint sensor.
11. The device of claim 10 , wherein the identification sensor comprises a digital camera and the device is configured to perform facial recognition on images captured with the digital camera.
12. The device of claim 10 , wherein the identification sensor is part of a cellular telephone mated to a sleeve comprising the pump head.
13. The device of claim 1 , wherein the predetermined event comprises detecting that environmental data is outside of a defined range or detecting administration of a full dosage amount.
14. A method of operating a programmable infusion device, comprising:
providing a portable infusion device configured to administer an infusate and comprising infusion parameters;
monitoring environmental data via one or more environmental sensors,
administering the infusate in accordance with the infusion parameters;
processing the environmental data to determine if a predetermined event has occurred; and
terminating infusion in response to the occurrence of the predetermined event.
15. The method of claim 14 , further comprising transmitting data from the one or more environmental sensors to an external device.
16. The method of claim 14 , further comprising obtaining identification data via one or more identification sensors for one or more of a patient and the infusate.
17. The method of claim 16 , wherein the one or more identification sensors comprise one or more of a digital camera or fingerprint sensor.
18. The method of claim 14 , wherein the one or more environmental sensors comprise one or more of temperature, flow, pressure, or air sensors.
19. The method of claim 14 , wherein the infusion parameters are provided by receiving an electronic input on a touch screen of the portable infusion device.
20. The method of claim 14 , further comprising displacing the infusate along a disposable fluid path.
21. The method of claim 14 , wherein the predetermined event comprises one or more of detection of environmental data outside of a defined range and detection of administration of a full dosage amount.
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Cited By (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20180200473A1 (en) * | 2017-01-13 | 2018-07-19 | Cooling Electronics Co., Limited | Electronic control circuit for alleviating altitude sickness and oxygen supply device |
US10441509B2 (en) * | 2018-03-16 | 2019-10-15 | Berkshire Biomedical, LLC | Computerized oral prescription administration with refillable medication dispensing devices and associated systems and methods |
USD888225S1 (en) | 2018-04-30 | 2020-06-23 | Smith & Nephew Asia Pacific Pte. Limited | Pump and canister assembly for negative pressure wound therapy |
JP2020103621A (en) * | 2018-12-27 | 2020-07-09 | 之博 矢萩 | Medical agent-holding molded body, syringe, and medical agent holding container |
US10729860B1 (en) | 2019-05-22 | 2020-08-04 | Berkshire Biomedical, LLC | Computerized oral prescription administration for securely dispensing a medication and associated systems and methods |
US10973693B2 (en) | 2015-05-18 | 2021-04-13 | Smith & Nephew Plc | Negative pressure wound therapy apparatus and methods |
WO2021108286A1 (en) * | 2019-11-25 | 2021-06-03 | Bayer Healthcare Llc | System and method utilizing an integrated camera with a fluid injector |
US11097085B2 (en) | 2017-01-13 | 2021-08-24 | Berkshire Biomedical, LLC | Computerized oral prescription administration devices and associated systems and methods |
US11389582B2 (en) | 2017-09-29 | 2022-07-19 | T.J. Smith And Nephew, Limited | Negative pressure wound therapy apparatus with removable panels |
US11395870B2 (en) | 2017-02-15 | 2022-07-26 | Smith & Nephew Asia Pacific Pte. Limited | Negative pressure wound therapy apparatuses and methods for using the same |
US11426509B2 (en) | 2015-08-13 | 2022-08-30 | Smith & Nephew, Inc. | Systems and methods for applying reduced pressure therapy |
US11559619B2 (en) | 2018-04-30 | 2023-01-24 | Smith & Nephew Asia Pacific Pte. Limited | Systems and methods for controlling dual mode negative pressure wound therapy apparatus |
US11642450B2 (en) | 2017-12-29 | 2023-05-09 | T.J. Smith And Nephew, Limited | Negative pressure wound therapy apparatuses and methods for using the same |
US11744932B2 (en) | 2018-05-23 | 2023-09-05 | T.J.Smith And Nephew, Limited | Systems and methods for determining blockages in a negative pressure wound therapy system |
US11806468B2 (en) | 2018-03-19 | 2023-11-07 | T.J.Smith And Nephew, Limited | Securing control of settings of wound therapy apparatuses |
US11872368B2 (en) * | 2018-04-10 | 2024-01-16 | Tandem Diabetes Care, Inc. | System and method for inductively charging a medical device |
US11955829B2 (en) | 2018-04-30 | 2024-04-09 | Smith & Nephew Asia Pacific Pte. Limited | Power source charging for negative pressure wound therapy apparatus |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP3544658A1 (en) | 2016-11-22 | 2019-10-02 | Sorrel Medical Ltd. | Apparatus for delivering a therapeutic substance |
EP3632487A1 (en) | 2018-10-05 | 2020-04-08 | Sorrel Medical Ltd. | Triggering sequence |
AU2020219044B2 (en) * | 2019-02-04 | 2023-01-12 | Becton, Dickinson And Company | System, method, and product for identifying a lumen |
CN112295051B (en) * | 2019-07-26 | 2022-04-19 | 深圳迈瑞科技有限公司 | Infusion pump and rapid injection method thereof |
WO2021038591A1 (en) * | 2019-08-26 | 2021-03-04 | Tarun Verma | A portable and wearable syringe infusion pump |
CN112516408A (en) * | 2020-11-09 | 2021-03-19 | 微泰医疗器械(杭州)有限公司 | Insulin bolus infusion control method, device and system and insulin pump device |
CN112472913A (en) * | 2020-11-09 | 2021-03-12 | 微泰医疗器械(杭州)有限公司 | Infusion control method and device, infusion system and pump body device |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4758228A (en) * | 1986-11-17 | 1988-07-19 | Centaur Sciences, Inc. | Medical infusion pump with sensors |
US5368562A (en) * | 1993-07-30 | 1994-11-29 | Pharmacia Deltec, Inc. | Systems and methods for operating ambulatory medical devices such as drug delivery devices |
US6162194A (en) * | 1998-05-20 | 2000-12-19 | Apollo Camera, Llc | Surgical irrigation apparatus and methods for use |
US20140194817A1 (en) * | 2012-06-06 | 2014-07-10 | Zyno Medical, LLC. | Medical pump with operator-authorization awareness |
US20150025498A1 (en) * | 2013-07-19 | 2015-01-22 | Asante Solutions, Inc. | Infusion Pump System and Method |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE60115707T2 (en) | 2000-12-21 | 2006-08-10 | Insulet Corp., Beverly | REMOTE CONTROL MEDICAL DEVICE |
TW557605B (en) * | 2002-06-28 | 2003-10-11 | Advanced Antenna Technology Nt | Diversified printing circuit planar array antenna |
CA2651160C (en) * | 2006-05-04 | 2014-12-16 | Flowserve Management Company | Handwheel torque limitor |
CN102369029A (en) * | 2009-02-04 | 2012-03-07 | 赛诺菲-安万特德国有限公司 | Medical device and method for providing information for glycemic control |
WO2011014704A2 (en) * | 2009-07-30 | 2011-02-03 | Tandem Diabetes Care, Inc. | Infusion pump system with disposable cartridge having pressure venting and pressure feedback |
RU2013149322A (en) * | 2011-05-10 | 2015-06-20 | Инсьюлин Медикал Лтд | DEVICE, SYSTEM AND METHOD FOR SIMPLIFYING DELIVERY OF MEDICINES USING A SYRINGE AND FOR MANAGING SUCH DELIVERY |
US9381297B2 (en) | 2012-06-07 | 2016-07-05 | Tandem Diabetes Care, Inc. | Sealed infusion device with electrical connector port |
JP6402099B2 (en) * | 2012-07-10 | 2018-10-10 | ベクトン ディキンソン フランス | Integrated injection system and communication device |
-
2016
- 2016-01-22 CN CN201680018655.9A patent/CN107427635A/en active Pending
- 2016-01-22 WO PCT/US2016/014470 patent/WO2016122976A1/en active Application Filing
- 2016-01-22 US US15/004,828 patent/US9901672B2/en active Active
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4758228A (en) * | 1986-11-17 | 1988-07-19 | Centaur Sciences, Inc. | Medical infusion pump with sensors |
US5368562A (en) * | 1993-07-30 | 1994-11-29 | Pharmacia Deltec, Inc. | Systems and methods for operating ambulatory medical devices such as drug delivery devices |
US6162194A (en) * | 1998-05-20 | 2000-12-19 | Apollo Camera, Llc | Surgical irrigation apparatus and methods for use |
US20140194817A1 (en) * | 2012-06-06 | 2014-07-10 | Zyno Medical, LLC. | Medical pump with operator-authorization awareness |
US20150025498A1 (en) * | 2013-07-19 | 2015-01-22 | Asante Solutions, Inc. | Infusion Pump System and Method |
Cited By (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10973693B2 (en) | 2015-05-18 | 2021-04-13 | Smith & Nephew Plc | Negative pressure wound therapy apparatus and methods |
US11426509B2 (en) | 2015-08-13 | 2022-08-30 | Smith & Nephew, Inc. | Systems and methods for applying reduced pressure therapy |
US20180200473A1 (en) * | 2017-01-13 | 2018-07-19 | Cooling Electronics Co., Limited | Electronic control circuit for alleviating altitude sickness and oxygen supply device |
US11097085B2 (en) | 2017-01-13 | 2021-08-24 | Berkshire Biomedical, LLC | Computerized oral prescription administration devices and associated systems and methods |
US11395870B2 (en) | 2017-02-15 | 2022-07-26 | Smith & Nephew Asia Pacific Pte. Limited | Negative pressure wound therapy apparatuses and methods for using the same |
US11389582B2 (en) | 2017-09-29 | 2022-07-19 | T.J. Smith And Nephew, Limited | Negative pressure wound therapy apparatus with removable panels |
US11642450B2 (en) | 2017-12-29 | 2023-05-09 | T.J. Smith And Nephew, Limited | Negative pressure wound therapy apparatuses and methods for using the same |
US10441509B2 (en) * | 2018-03-16 | 2019-10-15 | Berkshire Biomedical, LLC | Computerized oral prescription administration with refillable medication dispensing devices and associated systems and methods |
US11412983B2 (en) | 2018-03-16 | 2022-08-16 | Berkshire Biomedical Corporation | Computerized oral prescription administration with refillable medication dispensing devices and associated systems and methods |
US11806468B2 (en) | 2018-03-19 | 2023-11-07 | T.J.Smith And Nephew, Limited | Securing control of settings of wound therapy apparatuses |
US11872368B2 (en) * | 2018-04-10 | 2024-01-16 | Tandem Diabetes Care, Inc. | System and method for inductively charging a medical device |
US11559619B2 (en) | 2018-04-30 | 2023-01-24 | Smith & Nephew Asia Pacific Pte. Limited | Systems and methods for controlling dual mode negative pressure wound therapy apparatus |
USD888225S1 (en) | 2018-04-30 | 2020-06-23 | Smith & Nephew Asia Pacific Pte. Limited | Pump and canister assembly for negative pressure wound therapy |
US11955829B2 (en) | 2018-04-30 | 2024-04-09 | Smith & Nephew Asia Pacific Pte. Limited | Power source charging for negative pressure wound therapy apparatus |
US11744932B2 (en) | 2018-05-23 | 2023-09-05 | T.J.Smith And Nephew, Limited | Systems and methods for determining blockages in a negative pressure wound therapy system |
JP2020103621A (en) * | 2018-12-27 | 2020-07-09 | 之博 矢萩 | Medical agent-holding molded body, syringe, and medical agent holding container |
US10729860B1 (en) | 2019-05-22 | 2020-08-04 | Berkshire Biomedical, LLC | Computerized oral prescription administration for securely dispensing a medication and associated systems and methods |
WO2021108286A1 (en) * | 2019-11-25 | 2021-06-03 | Bayer Healthcare Llc | System and method utilizing an integrated camera with a fluid injector |
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US9901672B2 (en) | 2018-02-27 |
CN107427635A (en) | 2017-12-01 |
WO2016122976A1 (en) | 2016-08-04 |
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